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  ANNEX I 
 
COMMENTS BY THE PARTIES ON THE REPLIES BY THE 
SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL 
 
 
Contents Page 
Annex I-1 Comments by the United States on the replies by the scientific 
experts to questions posed by the Panel (31 January 2005) I-2 
Annex I-2 Comments by Canada on the replies by the scientific experts to the 
questions posed by the Panel (31 January 2005) I-35 
Annex I-3 Comments by Argentina on the replies by the scientific experts to 
the questions posed by the Panel (31 January 2005) I-80 
Annex I-4 Comments by the European Communities on the replies by the 
scientific experts to the questions  posed by the Panel (28 January 
2005) I-197 
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  ANNEX I-1 
 
COMMENTS BY THE UNITED STATES ON THE REPLIES BY THE 
SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL 
31 JANUARY 2005 
 
 
TABLE OF CONTENTS  
 
I. INTRODUCTION ....................................................................................................................2  
II. COMMENTS ON EXPERTS' RESPONSES .........................................................................4  
A. GENERAL QUESTIONS .................................................................................................................4  
B. ISSUE 1 (APPLICATION -SPECIFIC QUESTIONS )..........................................................................10  
C. ISSUE 2 (MEMBER STATE SAFEGUARD MEASURES ).................................................................22  
D. ADDITIONAL QUESTIONS ..........................................................................................................32  
 
 
I. INTRODUCTION 
1. As previously explained, the United States has not identified any dispositive scientific or 
technical issues with respect to which the advice of scientific or technical experts is required.  
Nonetheless, the United States believes that the experts' responses to the Panel's detailed and 
thoughtful questions are helpful in providing a bette r understanding of some of the scientific issues 
raised by the EC.  Moreover, as explained below, the United States submits that the expert advice 
provides further support for a finding that the EC's me asures are inconsistent with the EC's obligations 
under the WTO Agreement.     
 
2. The key issue in this dispute is whether th e EC adopted a moratorium on biotech approvals.  
The official organs of the EC – the Commission, the Council, the Parliament, and the member States – 
have all acknowledged the existence of a moratorium, and it is only in the context of this particular 
dispute that the EC denies its existence.  As the United States has explained, scientific or technical 
advice is not required to reach a fi nding on this central issue.  Fo r example, the EC argues that the 
statements of its officials announcing and acknowle dging the moratorium are of no consequence for 
the purposes of this dispute, and the EC cannot ex plain the many instances where applications were 
stalled for one year or more in the absence  of any outstanding requests for information.  The weight to 
be placed on these important types of evidence turn s on legal issues and non- technical questions of 
fact.  In short, the Panel does not need to turn to scientific advice to reach a finding that the EC did, in 
fact, adopt a moratorium on biotech approvals.   
 
3. At the same time, and as explained in the US  Supplementary Rebuttal, the United States most 
certainly does not agree with the EC's assertions th at all questions posed by EC regulators in the 
processing of product applications resulted from the legitimate need for additional scientific 
information.  To be sure, the United States has never claimed that all requests for additional 
information were unwarranted.  However, the Un ited States has explained that many types of 
questions were unnecessary and were used to promot e delay and perpetuate the moratorium.  Thus, 
although findings by the Panel that particular questions were scientifically unnecessary for the assessment of the product are 
not required  to establish the existence of the moratorium, such findings 
would provide further support  for the existence of the moratorium.    WT/DS291/R/Add.7 
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4. And, in fact, the advice of the experts provid es compelling evidence that many of the requests 
for information presented by EC regulators we re not necessary for the evaluation of the product 
applications.  For example, and as detailed in the body of this submission, the advice of the experts 
support findings that the following types of qu estions were unnecessary for conducting a safety 
assessment: 
– questions related to safety effects of antibiotic resistance marker genes;  
– repeated requests for additional and new types of molecular characterization; 
– requests for new and different types of detection methods; 
– requests for detailed information on envi ronmental effects when the application 
sought approval only for import and processing, and not for planting; 
– vague and open-ended requests for in formation on environmental effects; 
– requests for semi-chronic toxicity studies; 
– repeated requests for additional whole-food studies; and 
– requests for studies on the composition of food produced from animals that consumed 
biotech feed.   
The fact that many of the questions posed by EC regulators were not needed for the assessment of the 
biotech product applications both (i) supports a finding that the EC did not process the applications without "undue delay," and (ii) more generally, su pports a finding that the EC did in fact adopt a 
moratorium on biotech approvals.   
 
5. With regard to the member State safeguard measures, the EC does not dispute  that 
Community-level scientific bodies reached positive  assessments with respect to each product covered 
by a safeguard, and the EC does not dispute that the same bodies considered and rejected  the 
rationales that the member States put forth to jus tify the measures.  Moreover, the EC has not yet 
explained what specific scientific information mi ght serve as a basis for adopting these measures 
under the SPS Agreement, nor has the EC expl ained how or whether the Community-level 
assessments were incorrect.  
 
6. Where, as here, the defending Party has not even proffered a scientific basis for an SPS 
measure, there is no need to turn to expert a dvice to reach a finding under the SPS Agreement.  
Nonetheless, and as explained below, the expert r esponses further support findings that the safeguard 
measures are inconsistent with the EC obligati ons under the SPS Agreement.  For example, the 
experts explain that, contrary to member State claims, there is no basis related to food safety for adopting any of the member State safeguards, and th at there was no environmental basis for safeguard 
measures on products which received EC approval fo r import and processing (and not for planting).   
 
7. In a few cases, an expert pointed to some hypot hetical risks that, at the time of the adoption of 
the safeguard, the expert believed might have provided a basis for concern.  But even in these cases, the expert wrote that by this time (i.e., January 2005), the member States have had more than adequate time to conduct a full assessment of any such risks, and that in light of available risk management WT/DS291/R/Add.7 
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                                                       measures, total product bans were unnecessary.  In  short, the responses of the experts are of no 
assistance to the EC in defending the member State safeguards.  
 
II. COMMENTS ON EXPERTS' RESPONSES1 
A. GENERAL QUESTIONS  
Question 1:  On the basis of the information be fore the Panel, is there any scientific evidence to 
support the hypothesis that antibiotic resist ance marker genes (ARMG) pass from a biotech 
food or feed product to bacteria or other micro-or ganisms present in the human or animal gut?   
(a) If scientific evidence indicates that such an event could occur, what risks, if any, 
would arise from that event?  What is the comparative relevance or magnitude 
of this risk in relation to the likelihood of such a transfer from other sources of antibiotic resistance not involving the use of recombinant DNA technology? 
(b) If such risks have been identified, what is the likelihood of adverse effects to 
human or animal health, in light of the processing of raw biotech products into human food or animal feedstuffs?   
(c) Are these consequences relevant to the specific types of ARMG currently used in 
the products at issue in this dispute?  Please explain. 
(d) If such risks have been identified, wh at risk management options are available to 
mitigate those risks and what is their efficacy?   
8. The expert advice offered in response to these questions confirms that member State objections based on potential risks from antibiotic marker genes are not supported by scientific evidence.  Rather, the expert concurred with the opinions of the Scientific Committee on Plants (SCP) that examined this issue as part of their evalua tion of the products containing such genes: that the 
presence of these genes do not present a significant risk  to human health.  Professor Nutti explained as 
follows: 
 
"According to FAO/WHO (2000), DNA transfer from plants to microbial or mammal cells, under normal circumstances of dietary exposure, would require all the following events to occur: 
– the relevant gene(s) would have to be released, probably as a linear fragment; 
– the gene(s) would have to survive nucleases in the plant and in the 
gastrointestinal tract;  
– the gene(s) would have to compete for uptake with dietary DNA; 
 
1 The US comments are organized se quentially, following the numbering of the Panel's questions.  The 
United States has commented on those responses of the expert s that it believes are most relevant to the issues in 
this dispute.  The absence of comments on a particul ar question does not indicate either agreement or 
disagreement with the experts' responses to that question,  and the United States may,  as appropriate, provide 
comments on the issues raised in such responses at later stages of this proceeding.    WT/DS291/R/Add.7 
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  – the recipient bacteria or mammalian cells would have to be competent for 
transformation and the gene(s) would have to survive their restriction 
enzymes; and 
– the gene(s) would have to be inserte d in the host DNA by rare repair or 
recombinant events.  
There have been numerous experiments aimed at evaluating the possibility of transfer 
of plant DNA to microbes and mammalian cells. To date, there are no reports that 
marker genes in plant DNA transfer to these cells
The transfer of marker genes which confer  resistance to kanamycin, ampicillin and 
streptomycin to bacteria in the human gut  is unlikely to present a significant health 
impact since bacteria resistant to these antibiotics are already spread all over or are naturally found in the human gastrointestinal tract (Smalla et al., 1993; Calva et al., 
1996; Shaw et al., 1993; Smalla et al., 1997). Besides, kanamycin/neomycin and 
streptomycin are rarely used for humans due to their collateral effects (WHO 1993)."
2
9. Taking this advice into account, as well as the information previously provided by the United 
States,3 member State objections based on such concerns can at best be considered to raise merely 
theoretical risks.  
 
Question 3:  On the basis of the information be fore the Panel, is there any scientific evidence to 
support the hypothesis that wide-spread cultivation of Bt crops such as biotech maize of the Bt 
variety adversely affects non-target organisms  which may be exposed to such crops under 
typical agricultural practice? (See, inter alia , EC-149, EC-150, EC-151, EC-152) If so, how does 
this risk compare with risks to non-target organ isms arising from non-biotech applications for 
Bt toxins (i.e., the use of Bt toxin as an insecticide in conventional and organic farming)?  What 
risk management options are available to mitigate any resulting risks and what is their efficacy? 
10. With respect to Bt crops, specifically Bt cotton and/or Bt maize, both experts responding to 
this question provide similar assessments of the likelihood that Bt crops would be expected to 
adversely affect non-target organisms.  Dr. Andow states that while "there is some scientific evidence 
to support the hypothesis that wide-spread cultiv ation of Bt crops adversely affects non-target 
organisms ... this evidence is insu fficient to establish the hypothesis that such adverse effects are 
expected to occur."4  Similarly, Dr. Squires notes that "[t]he evidence is insufficient to confirm 
whether widespread cultivation of Bt crops in  Europe would affect non-target organisms."5   
 
                                                      
2 Dr. Marilia Regina Nutti's Answers to Questions to Experts. 
3 See US Supplementary Rebuttal, p. 36 et. seq;  See also US comments on Expert Answers to 
Questions 69-77  infra . 
4 Dr. David A. Andow's Answers to Questions to Experts, paras. 03.01, p. 2.  See also  Dr. Andow's 
Answers to Questions to Experts, para. 04.06, p. 7 (" Generally speaking, of all of the potential environmental 
risks of transgenic Bt crops, it can be said that resistan ce in the target pests is a real, tangible risk, while risks 
associated with gene flow and risks to non-target organisms are mostly only potential risks."); para. 03.16, p. 6 
("Coupled with paragraph 03.12, it is unlikely that eith er Bt crops or Bt insecticides will adversely effect 
mammals through direct toxicity.") 
5 Dr. Geoff R. Squire's Answers to Questions to Experts, "Responses to Questions 3 to 5." WT/DS291/R/Add.7 
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  11. While both experts acknowledge that these crops  may present "possible hazards" to non-target 
organisms from Bt crops,6 both experts agree that – even assuming the crops present more than a 
theoretical risk – risk management measures are avai lable to mitigate any potential risks.  Dr. Squire 
states that: 
 
"[i]t [is] much more easy to confine maize w ithin cropped fields than it is oilseed rape 
or beet, for example ... [I]f Bt maize was found to harm the in-field biodiversity, it 
should be feasible to reverse the effect by growing different crops in a rotation .  
Perhaps the main uncertainty is the effect of Bt maize on the soil food web ... . Effects 
in the soil would be harder to monitor because it is very difficult to assess soil 
biodiversity, particularly among bacteria a nd fungi.  Nevertheless , any adverse effects 
should be mitigatable through a rotation ."7
12. Dr. Andow similarly confirms that there are a variety of risk management options short of a 
complete ban that are available to deal with an y potential adverse effects on non-target organisms: 
 
"[r]isk management measures should be commensurate to the risk. ... Another 
approach [in the alternative to a complete ban] would be to limit the area of the transgenic crop until a reasonable assessme nt of the possible hazards and potential 
risks are completed.  As the information is gathered, the risk management measure 
can be modified consistent with the principl e of 'modification.'  For actual risks, such 
as the presumed risk to monarchs, geographic restrictions in use of the Bt crop could be considered ... Monitoring of the population at risk could be required, although this 
would likely be more expensive than restricting or managing use ... By no means should the Panel assume that this is an  exhaustive list of possible management 
options.  These are suggestions of approaches to risk management emphasizing avoiding risk.  Approaches that emphasize m itigation of risk or tolerance of risk 
could also be considered."
8
13. These experts' conclusions – that there is no scientific evidence supporting any actual, expected adverse effects on non-target organism s from Bt crops and that hypothesized potential 
hazards can be feasibly mitigated through risk mana gement measures or at least monitored and risk 
management measures subsequently  developed – clearly do not support the EC's claim that Bt crop 
applications were "duly" delayed by member Stat es' concerns about potential adverse effects on non-
target organisms.  As the United States explaine d in its Supplementary Rebuttal, certain member 
States simply objected to applications based on hypo thesized risks to non-target organisms, without 
considering any risk management options that mi ght be available to miti gate or avoid alleged 
hypothetical hazards.   
 
14. The experts' answers highlight the EC's oblig ation under the SPS Agreement to evaluate risk 
management options when consider ing applications for biotech pr oducts.  Under the SPS Agreement, 
an assessment must "... [e]valuat[e] the likelihood of entry, establishment or spread of a pest or 
                                                      
6 Dr. Andow's Answers to Questions to Experts, paras. 03.02-03.13, pps. 2-5 (Dr. Andow describes a 
potential risk to C. carnea  from Cry1Ab Bt maize, but opines that "the actual risk to C. carnea  would not be 
large." para. 03.09, p. 4); Dr. Squire's Answers to Questions to Experts, "Responses to Questions 3 to 5" ("The 
weight of the evidence ... generally favours the view that  little immediate toxic effect of Bt maize on the food 
web will occur in the field; but the evidence admits the possibility of chronic effects following long-term exposure to Bt maize.") 
7 Dr. Squire's Answers to Questions to Experts, "Responses to Questions 3 to 5" (emphasis added) 
8 Dr. Andow's Answers to Questions to Experts, paras. 03.17, 03.19-03.20, 03.23, p. 6.  WT/DS291/R/Add.7 
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  disease within the territory of an importing Memb er according to the sanitary or phytosanitary 
measures which might be applied, ... ."9  Accordingly, even allowing for such hypothetical risks, it 
was incumbent upon the EC to analyze the risk mana gement options available to mitigate or avoid 
entirely such effects and to make a decision on the application accordingly .  As the experts' statements 
confirm, such management options were available and should have been evaluated. 
 
Question 4: On the basis of the information befo re the Panel, is there any scientific evidence to 
support the hypothesis that the wide-spread cultivation of Bt maize or other, non-biotech 
applications of Bt toxins, leads to the emergen ce of Bt-resistant target organisms under field 
conditions?  If so, what risk management options exist to mitigate any resulting risks and what 
is their efficacy?  
15. Both experts similarly attest to the availab ility of risk management options to minimize the 
likelihood of emergence of Bt-resistant target organi sms as a result of Bt maize cultivation (as well as 
other, non-biotech applications of Bt toxins)  Dr. Andow notes:  
 
"[t]here are several risk management options  for Bt maize, but they are all concerned 
with reducing the selective advantage of resi stant alleles in populations of the target 
species.  The most widely used resistance management strategy for Bt maize (and all 
Bt crops) has been the high-dose/refuge strategy.  This has been used by the US 
Environmental Protection Agency.   For Bt maize, it is generally accepted that a 20% 
refuge is needed for the high-dose refuge strategy to be effective.  Low-dose Bt 
events will require a greater refuge.  There is no scientific consensus as to how big a refuge is needed... . Additional resist ance management strategies may become 
possible to develop after resistance in the ta rget pest is identified and characterized... . 
Theory has predicted that the high-dose/re fuge strategy will be efficacious ... These 
assumptions have been confirmed scientifically for European corn borer ( Ostrinia 
nubilalis ) in the northern US corn belt.  These  assumptions are likely for European 
corn borer in the southern US and in w estern Europe... . Hence it can be concluded 
that in some circumstances it is possible to predict that the high-dose/refuge strategy 
should be efficacious.  It is possible that the absence of detection of field resistance to 
Bt maize in the US is partially attribut ed to the efficacy of the high-dose/refuge 
strategy."
10
16. Dr. Squires states: 
 
"[t]he processes involved in Bt resistance and its management are generally appreciated by scientists, and mitigation stra tegies that have a strong scientific basis 
have been considered.  By the late 1990s , mathematical models of the population 
dynamics of resistant and susceptible bi otypes were being used to estimate the 
number of years for which the GM trait would remain effective in the face of genetic 
adaptation by the pest.  The point is that  sound scientific knowledge has been applied 
to this problem for several years... . The strategies [for mitigation] might involve providing refuges in or near the crop wher e resistant individuals do not have an 
advantage over resistant ones, periodically controlling the pest by other means and 
growing different 'types' of Bt maize, or Bt and non-Bt maize, either together or in sequence.  Mitigation will be much easier to implement where the existing ethos is 
                                                      
9 WTO Agreement on the Application of Sanitary and Phytosanitary Measures ("SPS Agreement"), 
Annex A, para. 4. 
10 Dr. Andow's Answers to Questions to Experts, paras. 04.07-04.08, 04.09, 04.10, 04.13, pp. 7-10. WT/DS291/R/Add.7 
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  sympathetic to integrated pest management based on genetic and ecological 
principles ... ."11
17. While the United States does not necessarily agre e with all of the specific details regarding 
the nature of the risk management measures descr ibed above, the United States does agree with the 
overall points the experts make regarding the availab ility of risk management options for dealing with 
Bt resistance.  The experts' testimony confirm th at resistance is not a new or unusual risk posed 
uniquely by biotech Bt maize.  Rather, it is a well-known potential risk posed by many non-biotech applications of insecticides, and consequently, well-understood, efficacious  mitigation strategies 
predicated on "strong scientific bases" have been de veloped (often referred to as insect resistance 
management (IRM) strategies)  
 
18. Given the availability and use of such IRM pl ans, the experts' conclusions confirm that the 
delay of Bt crop applications under the EC's pre-market approval system cannot be justified by 
alleged concerns over the emergence of Bt-resistance where objecting member States failed to address 
the validity of the IRM plans already submitted by applicants, particularly when those plans were 
deemed acceptable by the relevant EC scientific committees.   
 
Question 9:  In what ways does molecular charac terization inform the risk assessment for any 
particular biotech product?  Can a risk assessment be carried out in the absence of a 
comprehensive molecular characterizati on of each transformation event? 
19. The United States notes that Dr. Marion Healy's answer to question 9 supports the US 
position regarding the proper approach to  assessing the safety of biotech products.12  Dr. Healy states 
 
"[i]t is well accepted that assessment of ... foods from genetically modified organisms 
... involves the use of the 'comparative appro ach', whereby GM foods are compared to 
their counterpart foods produced using conve ntional techniques and which have been 
safely consumed over significant periods of time.  The objective of such a 
comparison is to identify any differences w ith the conventionally produced food.  
Any identified differences are then examined for their biological impact in terms of 
health and safety ... . The comparative approach ... encompass[es] three major 
elements: molecular characterisation of th e inserted gene (transgene); biochemical, 
structural and functional properties of the protein product from the inserted gene; and 
analysis of the composition of the food... ."13   
In other words, whether a differen ce has been detected is not in itself important:  what matters is 
whether that difference has any impact on health and safety.  Thus, when evaluating biotech 
applications, it is not sufficient for the EC only to  identify the existence of some difference between 
the biotech product and its conventional counterpart.  Rather, the pertinent issues are the the potential 
significance of that difference to human and environmental health and safety.   
 
20. Yet, the United States has provided numerous examples where member States objected to biotech applications simply because of an identif ied difference between the biotech product and its 
conventional counterpart (often times simply the ge netic modification itself), without examining the 
actual "biological impact" of such difference.
14  In doing so, these member States ignored the 
                                                      
11 Dr. Squire's Answers to Questions to Experts, "Responses to Questions 3 to 5." 
12 US Supplementary Rebuttal, paras. 128-133. 
13 Dr. Marion Healy's Answers to Questions to Experts, p. 1. 
14 See US Supplementary Rebuttal, Section IV.  WT/DS291/R/Add.7 
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  substantial evidence that existed for each appli cation establishing the product's safety.  Dr. Healy 
confirms, 
 
"[t]he totality of information available from these types of studies should be 
considered in coming to a view about the safety of the food; information from each 
element contributes to the assessment of safety  ... . [T]he molecular characterisation 
is not the only mechanism for identifying unintended effects and the information 
from such studies should be considered in conjunction with the information from the 
other elements of the safety assessment... . [T]he issue does arise as to how 
comprehensive the molecular characterisa tion should be in order to fulfil the 
requirements of an appropriate safety assessment.  In large part, the answer to this question depends on the type and quality of information available for the three 
elements of the safety assessment, the info rmation revealed from these studies and the 
state of knowledge about the gene(s) to be  transferred, the donor organism and the 
recipient organism."
15
21. The member States ignored the "totality of information" supporting the safety of particular biotech applications and requested additional information of questionable probative value.
16  Indeed, 
as Dr. Healy has noted in her answer to question 9, all of the plants at issue in this dispute contain relatively simple genetic modifications and have  been engineered to produce one or more well-
characterized proteins, a fact which member Stat es' requests for additional information failed to 
reflect.
17  Dr. Healy explains: 
 
"It must also be acknowledged that the commercially produced GMOs generated to 
date have utilised well defined crops as recipients of the genetic modification and 
well defined genetic elements in the transgenes.  Generally, the genetic elements have 
been extensively studied at both the DNA and protein levels.  Consequently there has 
been a high level of confidence in the assessments carried out to date. "18
22. Dr. Healy's expert opinion also provides additional support for the US contention that certain member States' requests for multiple whole food studies in which animals are fed with the biotech food for a period of several weeks to assess potential toxicity to humans and livestock were 
unfounded.
19  According to Dr. Healy, the comparative approach  
 
                                                      
15 Dr. Healy's Answers to Questions to Experts, pp. 1-2. 
16 For example, various member States reques ted, among other things: additional molecular 
characterization beyond the standard molecular character ization already provided by the applicant; additional, 
long-term or repeat dose (chronic) tests to prove the lack of the toxicity of the protein, despite the results of 
acute toxicity tests and the homology comparisons confirming the product's safety; additional whole food 
studies, despite the submitted safety results of compos itional analyses and of the initial whole food study; 
additional assessments on hybrid biotech plants despite the submitted data confirming the safety of the parental 
biotech lines; additional studies to confirm the safety of food derived from animals fed biotech feed, despite 
compositional analyses demonstrating that the nutritiona l makeup of the feed fell within normal biological 
ranges of variation established for non-engineered, commercially available feed and despite data showing that 
the introduced protein was rapidly degr aded or excreted, like any other diet ary proteins.  See US Supplementary 
Rebuttal, Section IV.B 
17 US Supplementary Rebuttal, paras. 134-138 (det ailing member States' demands that applicants 
conduct additional, long-term or repeat dose (chronic) tests to prove the lack of the toxicity of the protein 
involved in the biotech product). 
18 Dr. Healy's Answers to Questions to Experts, p. 3 (emphasis added). 
19 US Supplementary Rebuttal, paras. 143-144. WT/DS291/R/Add.7 
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  "is used in place of the traditional approach of assessing the safety of discrete 
chemicals added to, or present in, food ... that  are generally subjected to a range of 
toxicological evaluations in animal studies in a dose dependent manner.  (WHO, 
1987) The toxicological approach is not a ppropriate for whole foods because of the 
complex mixture of chemicals present in a whole food, some of which will be present 
at very low levels, and the difficulty of conducting meaningful dose response studies in animals while providing a nutritionally balanced diet."
20
23. Finally, in its Supplementary Rebuttal, the Un ited States explained that a pattern of deliberate 
delaying tactics by the EU was also illustrated by other types of scientifically baseless objections or 
requests for information that would have no relevance to an evaluation of the product's safety.  The United States cited as one example Italy's objec tions to the Bt corn CRY1F (1507) application
21 and 
the application for Roundup Ready maize NK 603.22  In those cases, Italy demanded, without 
providing any rationale, a proteomic analysis.   
 
24. Both experts' answers to question 9 support a finding that Italy's request was scientifically unjustified.  Dr. Andow states in response to Quest ion 9 that "[m]any other molecular methods are 
under development, including proteomics and others, but these are not yet ready for use in risk assessment now."
23  Similarly, Dr. Healy notes in response to question 9, "[s]ome of the technologies 
being developed are currently not appropriate for use in safety assessments as they do not yet provide 
any further assurance of safety or the results cannot be fully interpreted."24  
 
B. ISSUE 1 (APPLICATION -SPECIFIC QUESTIONS ) 
Bayer oilseed rape (Falcon GS40/90), C/DE/96/05 (EC chronology 62)
Question 10: Given the information before the Pa nel, including the notification by AgrEvo 
(EC-62/At.1-30) and the EC SCP's opinion (EC-62/At.74), was the information to assess the long-term effect of the newly expressed protein on the biogeochemical cycle and the food chain requested by the Italian CA (EC-62/At.95) necessa ry to ensure that conclusions of the safety 
assessment were valid? 
25. The response of the experts supports the US position that this type of general request for additional information – particularly when submitted  after a full safety evaluation by EC scientific 
committees – represents a delaying tactic rather than a good faith effort to evaluate the application.  As explained in the US supplementary rebuttal, an important delaying tactic was to ask for additional 
information regarding various vague, potential e nvironmental effects – such as vague requests for 
information on geochemical processes.
25  In his response, Professor Andow explains why this type of 
vague request is unwarranted:   
 
"A request for additional/clearer assessment of the possible effects on the environment would not be clear or specific enough to allow a notifier to know how to respond, and hence although information on the environmental impacts is necessary 
to ensure that conclusions of the safety assessment were valid, a general request for 
                                                      
20 Dr. Healy's Answers to Questions to Experts, p.1. 
21 US Supplementary Rebuttal, para. 188. 
22 US Supplementary Rebuttal, para. 194. 
23 Dr. Andow's Answers to Questions to Experts, para. 09.03, p.19. 
24 Dr. Healy's Answers to Questions to Experts, p. 3. 
25 US Supplementary Rebuttal, section IV.B.7.    WT/DS291/R/Add.7 
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  such an assessment would not be an appropria te way to request such information.  In 
a similar way the request by the Italian CA is not clear or specific enough to be 
considered necessary.  There are hundreds of possible processes in biogeochemical 
cycles that could be investigated, and thousands of possible ways to evaluate food chains.  Unless the Italian CA can point to prior regulatory precedents where these 
terms are clarified, the phrasing of the request is not scientifically justified.  Alternatively, had the Italian CA specifi ed certain biogeochemical cycles and food 
chains to assess, then it would be possible both for the notifier to assess them and for 
me to determine their necessity to ensure that conclusions of the safety assessment 
were valid."
26
26. Similarly, the United States explained in its supplementary rebuttal that requests for additional food toxicity tests were unwarranted wher e all of the available data indicated that the 
product presented no risk to food safety.
27  In her response, Professor Nutti supports the US position 
that the type of additional food safety informa tion sought by the Italian CA was unwarranted: 
 
"Based on the information provided by the a pplicant and the analysis carried out by 
the EC Scientific Committee for Plant (SCP) and following the Codex Guidelines, my understanding is that the request by the Italian CA (EC-62/At.95) was not necessary to ensure that conclusions for the safety assessment of the newly expressed protein in 
the food chain were valid. As pointed out by the EC SCP, the new protein has a very low potential for being allergenic or toxic and also is degraded within the gastric 
fluids. In my opinion, the conclusion of the EC SCP that the protein was safe for consumption in the food chain is correct and was based on sound scientific evidence, which was presented by the applicant."
28
Question 12. Given the information before the Pa nel, including the notification by AgrEvo 
and the conclusions of the EC SCP, was the information regarding the molecular characterization of this product requested by th e lead CA  (EC-62/At.106)  necessary to ensure 
that conclusions of the safety assessment were valid?  
27. This question regarding a request for additio nal molecular characterization – combined with 
the experts responses to this question – illustrates one of the themes of the US supplementary rebuttal.  
That is, when evaluating whether a request for information was warranted for conducting a safety 
assessment (or was instead a delaying tactic) one must consider all of the information provided by the 
applicant, and the importance of any additional  information not for the purposes of general scientific 
inquiry, but instead for the purpose of evaluating the safety of the product.   
 
28. Professor Snape, in his response, indicates that he personally woul d have preferred more 
information on molecular characterization, and in deed would even like to see types of data beyond  the 
additional data requested by the lead CA.  Professor Snape's opinion, however, is phrased in terms of 
what information he would like to see as a scientist specializing in genetic changes, and is not phrased 
in terms of what actual information is requi red to evaluate the safety of the product.29   
 
29. In contrast, Dr. Healy does consider the request for additional molecular characterization in 
the context of the entire application,  and with an eye to the ultimate goals of the EC approval process.  
                                                      
26 Andow Response, Question 10.   
27 US Supplementary Rebuttal, section IV.B.2.   
28 Nutti Response, Question 10.   
29 Snape Response, Question 12.   WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-12 
  
  In context, and with these goals in mind, Dr. Healy concludes that the request for additional data was 
not warranted: 
 
"Additional information of the sequences at the sites of insertion may reveal fine 
structural details and identify similarities and differences with the parental line at 
these sites.  Such detailed structural analyses usually aim to provide an indicator of unintended effects from the genetic modification.  However, in some cases it may be difficult to determine the biological signif icance of any sequence differences because 
of a lack of knowledge about the extent of sequence variation between individual organisms within the parental line.  Furthermore, other indicators of unintended effects, that are biologically meaningful, are obtained from other elements of the safety assessment (eg analysis of protein, composition of food). 
A comprehensive package of informati on was provided that addressed the key 
elements required in a safety assessment and there was no indication of any safety issues when all the available data was take n into account.  Furthermore, the pat/PAT 
gene/protein is well characterised, has been  utilised successfully in a number of crops 
and their resultant food products and w as derived from a well described organism. 
CONCLUSION:  The additional molecular characterisation requested by the Lead CA is unlikely to affect the conclusions of the safety assessment and was not 
necessary to ensure that the conclusions of the safety assessment were valid.  The 
totality of information provided in the dossier to that point in time were adequate to 
support the validity of the conclusions of the safety assessment without the need for 
the additional data requested in  the letter dated 2 April 2002."
30
Bayer hybrid oilseed rape (MS8/RF3), C/BE/96/01  (EC chronology 63)
 
Question 15:  Given the information before the Pane l, including the conclusions of the EC SCP, 
was the information regarding the assessment of the long-term effect of the newly expressed 
protein on the biogeochemical cycle and the food chain requested by the Italian CA (EC-63/At.87) necessary to ensure that conclusions of the safety assessment were valid?  
 
30. This question, and the experts' responses, ar e essentially the same as for Panel's Question 10 
on Exhibit 62.  In particular, Professor Andow's re sponse supports the US view that vague questions 
on unspecified environmental effects are unwarranted, and Professor Nutti's response supports the US view that when all available data indicates the absence of a food safety problem, it is unnecessary to request yet additional studies addressed to food safety.   
 
Question 16:  Given the information before the Panel, including the conclusions of the SCP, was the information regarding molecular characterizati on of this product requested by the lead CA 
(EC-63/At.107) necessary to ensure that conclusi ons of the safety assessment were valid?   
 
31. Dr. Healy's response to this question once ag ain emphasizes the need to evaluate the entire 
application in order to determine whether a request for additional information is necessary to evaluate the safety of the product, or instead is a question for theoretical scientific inquiry.  As in her answer to the Exhibit 62 question on molecu lar characterization, Dr. Healy explains why no further molecular 
characterization was required to evaluate the safety of the product: 
 
                                                      
30 Healy Response, Question 12.    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-13 
 
 
                                                       "The additional molecular characterisation da ta sought by the lead CA in 2002 were 
not required to demonstrate the safety of food products derived from MS8, RF3 or 
MS8xRF3 hybrid lines. The rational[es] for this view are: 
– Finely detailed molecular analysis of a defined chromosomal region in 
commercially adapted plant lines such as oilseed rape is likely to reveal 
minor nucleotide differences between vari ous lines that have no significance 
with respect to the safety of derived food products. In the absence of an 
equivalent nucleotide analysis from a number of commercial food-producing 
oilseed rape lines, these data do not co ntribute substantially to the bank of 
information that is necessary to adequately characterise MS8 and RF3 at the molecular level. Moreover, it is not clear  how such data should be interpreted 
in an assessment of transgenic plants. 
– The data provided at that point in tim e (i) allowed adequate description of the 
insertion events in both transgenic lin es, (ii) was sufficiently detailed, 
presented clearly and of acceptable quality , and (iii) was consistent with a 
generally accepted approach to the mol ecular characterisation of transgenic 
crops used for food production.  
– The most significant elements of the assessment of MS8 and RF3 oilseed 
rape lines more appropriately focus on the molecular characterisation of the 
insertion events and the resultant novel gene products, particularly in terms of 
their potential toxicity and allergenicity. The food products derived from transgenic oilseed rape are likely to contain at most only trace amounts of plant proteins due to processing. Comparative compositional data from the seeds of both transgenic lines and the corresponding isogenic lines therefore 
provides necessary information to determine unintended effects. 
Conclusion:  The totality of information provided in the dossier to that point in time 
contained sufficient information to support the validity of the conclusions of the 
safety assessment without the need for the additional molecular characterisation data requested in the letter of the Biosafety Council dated 28 March 2002."
31
Question 17:  Were detection meth ods commercially available in 2001 sufficient to enable the 
detection of the transgenic proteins expressed by the plant line hybrid oilseed rape MS8/RF3?   
Given the information before the Panel, including the SNIF (EC-63/At.109) and the updated environmental risk assessment (EC-63/At.110-14 0), was additional information regarding a 
quantitative detection method (EC-63/At.141) necessa ry to ensure that conclusions of the safety 
assessment were valid? 
 
 
 
 
 
 
31 Healy response, Question 16.   WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-14 
  
                                                       32. Both experts that responded to this question were of the opinion that detection methods were 
available in 2001,32 and that additional information regard ing a quantitative detection method were 
not required for a safety assessment.33    
 
Question 18:  Given the information before th e Panel, including the SNIF and the updated 
environmental risk assessment (referenced ab ove), was the information regarding molecular 
data requested by the CA (EC-63/At.144) necessar y to ensure that conclusions of the safety 
assessment were valid? 
 
33. Dr. Healy's answer to this question exemplifies another type of problem with some EC 
requests for additional data.  In particular, give n the continual progress of science and technology, 
finer tests are developed over time.  But, if an a pplication is always required to be updated with the 
results of the latest testing methodologies, no application would ever be approved.  Rather, as Dr. 
Healy explains, the pertinent question is whether, in  the context of the overall application, the results 
of a newly-developed test are actually required for a safety assessment of the product.  Dr. Healy 
explains this point in the context of Exhibit 63: 
 
"Given the pace of advancing knowledge in the field of molecular biology and plant 
biotechnology and the rapidly evolving tec hnical capabilities, for a foreseeable time, 
there will often be a discrepancy between the scientific data submitted in a dossier for 
assessment, and the information possible from the most recently developed experimental techniques. In the specific case of the frequently updated dossier on MS8, RF3 and hybrids, it is clear from the wo rding of the request to the company that 
the additional information sought is for the purpose of "simply" making the file 
consistent with the current Belgian guide lines on molecular data.  This additional 
information does not add substantially to the weight of evidence that supports the lack 
of human health and safety concerns associate d with the use of the transgenic oilseed 
rape.  
...   
Conclusion:  The additional information s ought by the CA in the email of 14 July 
2003 (EC 63-144) on molecular data was requested to update the dossier to new 
guidelines and was not necessary to ensure the conclusions of the safety assessment were valid."
34
Question 19:  Given the information before the Panel, including the SNIF, the updated environmental risk assessment and the clarific ation provided by the notifier (EC-63/At.147), 
was the information regarding ecological effect s of this product on agricultural systems 
 
32 Healy Response, Question 17 ("Conclusion:   The available evidence indicates that 
immunoassay-based detection methods suitable for the detection of PAT protein in MS8xRF3 hybrid transgenic 
plants were commercially available as early as 2000. "); Nutti Response, Question 17 ("My conclusion is that 
the method presented was technically sufficient for th e safety assessment, although it would have to be 
validated.").     
33 Healy Response, Question 17 ("Conclusion:  Additional information regarding an event specific, 
quantitative detection method requested in  February 2003 is not necessary to ensure that the conclusions of the 
safety assessment are valid."); Nutti Response, Qu estion 17 ("Although a quan titative method will provide 
relevant information for labelling and to the consumer, it is not necessary to ensure the validity of the safety 
assessment. ")   
34 Healy Response, Question 18.    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-15 
 
 
  requested by the lead CA (EC-63/At.149) necessary to ensure that conclusions of the safety 
assessment were valid?  
 
34. This question again illustrates the problem with vague information requests addressed to unspecified and highly speculative possible effect s on the environment.  Each of the experts 
responding to this questions has somewhat different views on what, if any, 
specific  environmental 
issues might have been appropriate for further inqu iry, but all agree that an applicant cannot be 
expected to respond to an entirely open-ended inquiry  that does not specify the environmental concern 
or the specific matter to be investigated.  For example: 
 
Professor Andow:   
 
"As there are literally hundreds of species of non-target organisms that could be 
tested, it can always be argued that more sp ecies should be evaluated.  Indeed, several 
important ecological functional groups were not evaluated, including parasitoids and 
detritivores.  Without a specific reason, it is difficult to argue that testing a parasitoid 
is necessary for the risk as sessment.  A case could be made that a detritivore would 
have been a better choice for study than epigeal predators.  However, if this was the 
specific concern of the lead CA, it would have been appropriate to clarify the point.  
Hence, I conclude that the request by the lead CA for more information on point 5 
was not necessary to ensure that conclusions of the safety assessment were valid. "35   
Professor Snow:  
 
"The vagueness of this request and the lack  of related information from the notifier 
make it difficult to provide a clear answer to this question from the Panel.  
The lead CA asked for information about effects on "farmland diversity (macro-fauna, weed flora and microbial soil ecosystem), food web integrity (trophic structure), population dynamics of key species, life-cycles, etc." (EC-63/At. 149 translation).  Although this request seems to ask for some unnecessary data (and the request is quite vague), several Member St ates were concerned about the ecological 
effects of more intensive herbicide use.  I assume that this is the focus of concern - 
that more information was requested to determine the effects of cultivating new herbicide-tolerant crops on the weed plants  that support insect and animal populations 
in farmland habitats in these countries.    
Realistically, this is a difficult set of ques tions to answer, regardless of whether one 
uses basic theory or empirical research.  As noted above, the indirect effects of introducing herbicide-tolerant crops to  countries like the UK are still being 
investigated, so in this sense the request ed information could be considered as 
necessary.  
However, it not feasible to obtain scientific data on all of the processes 
listed by the CA without extensive multi-year studies.  Even the Farm Scale 
Evaluations are too short and too small-scal e to answer these questions (e.g., Andow 
2003, Squire et al. 2003).  Adverse effects on flora and fauna are mentioned in SPS and ISPM 11, 
but it is not possible to test for all of these effects prior to deregulation.  
                                                      
35 Andow Response, Question 19 (emphasis added).   WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-16 
  
  Instead, scientific committees typically u se their best judgement to recommend 
approving or denying applications for marketing."36
Professor Squire:   
 
"The updated environmental risk assessment  is comprehensive on topics for which 
data are available. The further information on ecological effects re quested by the lead 
CA was clearly not available, and could only be in existence if there had been either 
large scale experimental measurements on the habitats typical of where the crop 
would be grown commercially or specially  commissioned experiments on trial crops, 
as in the UK's Farm Scale Evaluations. Since cropping with this variety and its 
herbicide has potentially new effects on the ar able flora (i.e. different from those of 
other oilseed rape varieties with other herb icides), which may be severely depleted in 
any case, it is legitimate to ask what such effects might be. However, the general 
matter of the need for a comparator is relevant here  (Notes, paragraphs 7-10). Surely 
it is incumbent on both sides in the argument to proffer their standard or comparator 
against which the new technology should be judged. "37
35. In sum, although the experts may have somewh at differing views on potential environmental 
effects, all agree that it is not possible for an app licant to respond to vague requests asking for data on 
every possible effect on the environment, no matte r how remote.  Instead, such vague, open-ended 
questions are a formula for endless delays.   
 
Monsanto Roundup Ready oilseed rape (GT73), C/NL/98/11   (EC chronology 70)
 
Question 27. Given the information before the Panel, including the notification, was the 
information regarding feed safety aspects of  this product requested by the Netherlands 
(EC-70/At.8 and 13) necessary to ensure that co nclusions of the safety assessment were valid? 
 
36. In its Supplementary Rebuttal, the United States explained that continual requests for 
additional animal feeding studies were not require d for safety assessment, but instead were commonly 
used as a delaying tactic.38  Professor Nutti's response to Question 27 provides yet another example 
where requests for additional feeding studies were not required in order to evaluate the safety of the 
product.  Professor Nutti explains: 
 
"Based on the information provided by the applicant in EC-070/At.8 and 13, and the analysis done by the EC SCP and accordi ng to the Codex Guideline for the Conduct 
of Food Safety Assessment of Foods De rived from Recombinant-DNA Plants (Page 
4, paragraph 53), some foods may require a dditional testing; regarding animal feeding 
studies, extra studies may be warranted if ch anges in the bioavailability of nutrients 
are expected or if the composition is not comparable to conventional foods. Although 
the product was concluded to be substan tially equivalent, the notifier carried out 
animal feeding studies with rainbow trout, quail, broilers and lamb. In all these 
studies, no differences were detected am ong the animals fed conventional and GM 
                                                      
36 Snow Response, Question 19 (emphasis added).   
37 Squire Response, Question 19 (emphasis added).   
38 US Supplementary Rebuttal, paras. 182-184.    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-17 
 
 
  oilseed rape based feeds. Therefore, it is concluded that the studies requested by the 
Netherlands were not necessary to en sure the product's safety assessment."39
Monsanto Roundup Ready corn (NK603), C/ES/00/01  (EC chronology 76)
 
Question 37.  Given the information before the Pa nel, including the notification (EC-76/At.1-2 
and 27), was further information regarding mol ecular characterisation, nutritional analysis, 
and environmental impact requested by the le ad CA (EC-76/At.6) necessary to ensure that 
conclusions of the safety assessment were valid?  
 
37. Experts responded to the nutritional analysis a nd environmental impact parts of this question, 
and in both cases the experts believed that the further information sought by the lead CA was not 
needed to assess the product.   
 
38 With respect to nutritional analys is, Professor Nutti explains as follows: 
 
"Based on EC-76/At.1-2 and 27, and regard ing nutritional analysis, compositional 
analysis of NK603 maize grain has demons trated substantial equivalence with 
traditional maize. This is supported by lack  of differences show n in the results of 
feeding NK603 to broiler chickens compared  with birds fed with NK603 parental line 
or with five commercial reference lines, as well as repeated dose feeding studies in 
rats, which contribute to determine the composition and nutritional equivalence. 
Whatever studies were further requested by the lead CA in EC-76/At.6, such studies were not necessary to ensure that conclusions of the safety assessment were valid since all the relevant information had already been provided. In EC-76/At.27, the 
Spanish Biosafety Commission had already es timated that for the uses considered and 
at the current scientific and technical "state of the art", there was no scientific 
evidences which indicated any risk for hu man and animal health of NK603 maize."
40   
39. With respect to environmental impact anal ysis, the experts' responses indicate that it was 
unnecessary for the EC to conduct an in-depth analysis of environmental issues because the application was for 
import and processing , and not for cultivation.  Although Dr. Squire writes that 
some additional environmental information may r easonably have been sought, he does not support 
requiring all the detailed environmental data that might be called for if the application were for 
cultivation.41  Moreover, Dr. Andow explains in detail w hy the limitation of the application to import 
and processing reduces the amount of data that is required to assess the environmental safety of the product, and why the lead CA's questions  were not required to assess the product: 
 
"37.04.  I believe that none of the questions posed under environmental impact are necessary to ensure that conclusions of the safety assessment were valid. 
37.05.  Given that the notification is not for cultivation, whether survival is slightly better in continuous maize than in rotate d maize ignores the bigger point, which is 
that maize does not survive very well.  While the CA is correct in noting the 
difference, this difference is not necessary to ensure that conclusions of the safety 
assessment were valid. 
                                                      
39 Nutti Response, Question 27.   
40 Nutti Response, Question 37.   
41 Squire Response, Question 37. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-18 
  
  37.06.  While it is true that potential inter actions need to be looked into broadly and 
deeply if the GM crop were to be cultivated, it is not true that such an investigation is 
necessary for the present notification.  It would be better to focus attention on 
detecting accidental releases and quickly eliminating them. 
37.07.  Although it is true that detailed information on transferability of genetic 
material from the GM crop to other organism s is needed if the GM crop were to be 
cultivated, it is not true that detailed information is needed for the present 
notification.  Some information is neces sary to consider how gene escape can occur 
either during processing, storage or transport, but detailed information is not 
necessary. 
37.08.  As the GM plant is not to be cultivated under the present notification, information on herbicide application is not needed."
42   
Monsanto Roundup Ready corn (GA 21), C/ES/98/01 (EC chronology 78), C/GB/97/M3/2  (EC 
chronology 85)  
 
Question 40.  Given the information befo re the Panel, including the application 
(EC-85/At.25-26), questions by Denmark (EC-85/At.32) and responses to these questions (EC-85/At.41), was the additional information requested by Denmark (EC-85/At.42) necessary to ensure that conclusions of the safety assessment were valid?  
 
40. This application provides another example in  which a CA has requested additional animal 
feeding studies which are not required for a safety assessment of the product.  As Professor Nutti 
explains,  
 
"Base[d] on the information provided by the applicant (EC-85/At.25-56) and responses to the questions raised by Denmark (EC-85/At.41 and EC-85/At.32, respectively), regarding animal feeding studies, my understanding is that the applicant has provided sufficient relevant information. According to the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45- 2003, paragraph 53), additional animal 
testing will be required if the composition is not comparable to conventional foods, 
which is not the case of Mon santo's event corn GA 21."43
Monsanto/Syngenta Roundup Ready sugar beet, C/BE/99/01  (EC chronology 88)
 
Question 42.  Given the information before the Panel, including the notification (EC-88/At.1) 
and additional information provided by the notifier (EC-88/At.10-11), was the information 
regarding allergenicity, molecular characterisa tion, and gene transfer in digestive tracts 
requested by the lead CA (EC-88/At.12) necessary to ensure that conclusions of the safety 
assessment were valid?  
 
41. This question illustrates a case where the CA 's question may have been relevant to the 
assessment of the product, but where the applicant's original notification had provided the information 
sought by the CA.  Professor Nutti's response care fully analyzes this question, and concludes with 
respect to all three aspects (alle rgenicity, molecular characterization, and gene transfer) that the 
                                                      
42 Andow Response, Question 37.   
43 Nutti Response, Question 40.    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-19 
 
 
  requested  information had already been provided in  the application.  As a result, the lead CA's 
additional request resulted in needless de lay in the processing of the application.44   
 
Monsanto MaisGard Roundup Ready (MON 810 & GA21) corn (stack), C/ES/99/02  (EC 
chronology 94)  
 
Question 44.  Given the information before the Pane l, including the notification (EC-94/At.1-3), 
was the information requested by the Neth erlands(EC-94/At.12) concerning molecular 
characterization, DNA sequence analysis of the insert ion event, analysis of protein levels, effect 
of glyphosphate treatment, composition, toxico logy and the request for a study on dairy cows 
necessary to ensure that conclusions of the safety assessment were valid?  
 
42. Professor Nutti provided a detaile d analysis of four additional types of food-safety data 
requested by the Netherlands, and in each case she concluded that the information requested was not 
required for a safety assessment.   
 
43. For example, the applicant was asked to provi de a semi-chronic feeding study on mice, even 
though acute exposure studies and all other available data indicated that no such additional studies 
were required.  Professor Nutti explains as follows:   
 
"Based on Codex Alimentarius Guidelin es for the Conduct of Food Safety 
Assessment of Foods Derived from Re combinant-DNA Plants (CAC/GL 45-2003), 
paragraphs 34 to 43, Assessment of Possible T oxicity, we have at para 37 that the use 
of appropriate conventional toxicology or  other studies on the new substance may be 
necessary, if taking into account its function and exposure, there are doubts on the 
safety of the new substance.  In this case the applicant has provided in the dossier (EC-94/At.1-3), all the information usually requested for the food safety assessment, for toxicological assessment he presented safety studies on protein digestion in mammalian gastric and intestinal systems, acute gavage studies in mice, homology to known toxins and allergens and expos ure to human diet. Based on Codex 
Alimentarius Guidelines for the Conduct of Food Safety Assessment of Foods 
Derived from Recombinant-DNA Plants (CAC/GL 45-2003), paragraphs 53, my 
understanding is that additional animal feeding studies may be warranted for GM 
foods if changes in the biovailability of the nutrients are expected or if the composition of the GM food is not comparable to conventional food, that is not the 
case of the new hybrid MON 810x GA21 maize. My understanding is that the 
information submitted by the applicant was su fficient to ensure the validity of the 
safety assessment."
45
Syngenta Bt-11 sweet corn , (EC chronology 92)
 
Question 46.  Were detection methods commercially available in 2002 sufficient to enable the 
detection of the transgenic proteins expressed by the plant line Bt11 sweet corn? 
 
44. This question highlights an application wher e the processing was delayed by requests for the 
development of a detection method, when in fact a detection method was available to EC regulators.  
After a detailed analysis, Dr. Healy concludes that "that an immunoassay based detection method 
                                                      
44 Nutti Response, Question 42.   
45 Nutti Response, Question 44.   WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-20 
  
  suitable for the detection of Cry1A(b) protein in Bt-11 transgenic plants was commercially available 
in 2002."46
 
Bayer LibertyLink soybeans, (EC chronology 93)
 
Question 49.  Given the information before the Pa nel, including the application (EC-93/At.1-2), 
was additional information regarding nutritional and biochemical characterization and toxicity 
of the transgenic plant requested by the G reek and Italian authorities (EC-93/At.16-17) 
necessary to ensure that conclusions of the safety assessment were valid? 
 
45. This question provides an example where a CA  delayed an application by requesting food 
safety data on an  herbicide , when in fact herbicide residues are regulated through a different regime.  
As Professor Nutti explains,  
 
"Questions 1 and 2 [of the Italian authority] related to the herbicide treatment in the 
tests and possible residues of this treatmen t in the final product. My understanding is 
that the risk assessment conducted here is related to the GMO and not to the 
herbicide, so this information is not re levant for the conclusions of the safety 
assessment. It is important to point out that the herbicide residue in the product has to 
be  within the limits established by J EFCA and the Codex Alimentarius, so the 
herbicide has been assessed in a different study. Sometimes, companies that are 
carrying out the safety assessment of herbicide resistant GMOs, perform field tests 
with and without herbicides, but this is not the main objective of the evaluation, as we need to compare the transgenic and non tran sgenic crops and not the utilization of the 
herbicide."
47
Monsanto Roundup Ready corn (NK603), (EC chronology 96)
 
Question 53:  Given the information before the Pa nel, including the application (EC-96/At.1-2), 
was information regarding molecular characteriza tion, toxicity effects of unintended changes 
and compositional data requested by Gezondheitsraad (EC-96/At.7) necessary to ensure that 
conclusions of the safety assessment were valid?  
 
46. Nk603 Roundup Ready corn is another instan ce where a CA requested additional feeding 
studies, when existing studies and all other availabl e information indicated that no additional studies 
were required.  As Professor Nutti explained,  
 
"Question 2 [of the Gezondheitsraad] concerning the request for a semi chronic 
toxicity study in mice or rats, using maize grain or meal, in order to rule out possible undesired effects of additional, unidentified changes. Based on the Codex Alimentarius Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45-2003), paragraphs 34 to 43, 
Assessment of Possible Toxicity, we have at para 37 that the use of appropriate 
conventional toxicology or other studies on the new substance may be necessary, if 
taking into account its function and exposure, there are doubts on the safety of the new substance.  In this case the applicant has provided in the dossier (EC-96/At.1-2) all the information usually requested for the food safety assessment, for toxicological 
assessment he presented safety studies on CP4EPSPS protein digestion in mammalian 
                                                      
46 Healy Response, Question 46.   
47 Nutti Response, Question 49.    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-21 
 
 
  gastric and intestinal systems, acute gavage studies in mice, homology to known 
toxins and allergens and exposure to human diet. It was also confirmed that the GM 
maize was equivalent in composition and nutrition to the conventional counterpart. 
Therefore, in my opinion, there was no n eed for requesting a semi chronic toxicity 
study in mice or rats, using maize grain or meal, in order to rule out possible undesired effects of additional, unidentified changes."
48  
Pioneer LibertyLink and Bt (T25 x MON 810) corn (stack), (EC chronology 101)
 
Question 57:  Given the information before the Pa nel, including the application (EC-101/At.1-3) 
and the additional information provided by Pioneer (EC-101/At13),  was additional information molecular characterization, field trials, seconda ry plant metabolites, and toxicological tests 
requested by the Netherlands (E C-101At.14) necessary to ensure that conclusions of the safety 
assessment were valid?  
 
47. This product presents yet another exampl e where the CA requested unnecessary semi-chronic 
oral toxicity studies.  Both Professor Nutti and Pr ofessor Andow state their view that such studies 
were not required in light of the studies already provided showing the absence of toxicity.49   
 
Monsanto/Syngenta Roundup Ready sugar  beet (77), (EC chronology 102)
 
Question 58.  Given the information before the Pa nel, including the application (EC-102At.1-20) 
and the information provided by Monsanto/Novartis (EC-102/At.22, 26 and 27-30), was additional information regarding food safety a ssessment of derived proteins requested by the 
Netherlands  (EC-102/At.32) necessary to ensure th at conclusions of the sa fety assessment were 
valid?  Did the food safety assessments provide d by the applicant follow the Codex Guideline 
for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. 
 
48. Again, the only expert to examine the i ssue – Professor Nutti – states that additional food 
safety data (in the form of semi-chronic toxicity studies) were not required.  With respect to the second half of the question, Professor Nutti states her view that the applicant did in fact follow the 
relevant Codex guidelines: 
 
"Based on the Codex Alimentarius Guide lines for the Conduct of Food Safety 
Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45-2003), paragraphs 34 to 43, Assessment of Possible T oxicity, we have at para 37 that the use 
of appropriate conventional toxicology or  other studies on the new substance may be 
necessary if, taking into account its function and exposure,  doubts about the safety of 
the new substance remain. In this case, the applicant has provided in the dossier (EC-102/At.1-20) all the information usually requested for the food safety assessment. Also, for the toxicological assessment he presented safety studies on protein digestion in mammalian gastric and in testinal systems, acute gavage studies in 
mice, homology to known toxins and allergens, and exposure to hum-an diet. 
                                                      
48 Nutti Response, Question 53.   
49 Nutti Response, Question 57 ("Therefore, the reque st from the Netherlands for semi-chronic oral 
toxicity study on mice or rats with maize grain, were not necessary to ensure that conclusions of the safety 
assessment were valid, as the data provided by the notif iers confirmed that T25 and MON 810 are substantially 
equivalent to other commercial maize."); Andow Response, Question 57 (semi-chronic study "not necessary to 
ensure conclusions of the safety assessment were valid."). WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-22 
  
  Based on the Codex Alimentarius Guidelines for the Conduct of Food Safety 
Assessment of Foods Derived from Re combinant-DNA Plants (CAC/GL 45-2003), 
paragraphs 53, my understandi ng is that additional animal feeding studies may be 
warranted for GM foods if changes in the bi ovailability of the nutrients are expected 
or if the composition of the GM food is not comparable to conventional food, that is not the case of Monsanto/Syngenta Roundup Ready sugar beet ."
50
C. ISSUE 2 (MEMBER STATE SAFEGUARD MEASURES ) 
Oilseed Rape MS1 x RF1 (notification C/UK/94/M1/1) 
 
French Safeguard measure (Questions 59-61)  
 
49. The United States notes several points of interest with respect to the experts' advice on this notification.  First, the experts have confirmed that the evidence establishes th at the French safeguard 
measure cannot be justified on the grounds of any pote ntial risk to human or animal health.  As Dr. 
Nutti has explained,  
 
"I would like to point out that there [was ] no scientific evidence regarding to food and 
feed safety assessment, for animal and human consumption, on which France['s safeguard measure] could be based."
51     
50. In addition, the advice from the experts with respect to risk management indicates that the 
absence of a basis for a total product ban, and that in stead risk management me asures were available.  
In his response to question 61, Dr. Andow concludes that    
 
"Several other risk management options [than the French safeguard measure] could 
also have been justified in November 1998 and July 2001.  Risk management 
strategies include risk avoidance, risk mitig ation, and risk tolerance.  In 1998 and 
2001 mitigation and tolerance strategies we re probably inappropriate....One risk 
avoidance strategy would have been to allo w limited planting in a restricted region.  
In the first year, this could have been at a scale of a large field trial, and build up from 
there.  This would allow determination of scale effects.  Another strategy is outlined 
in paragraph 3.19. 
Today several alternative risk management op tions are available.  In addition to risk 
avoidance as in the previous paragraph,  risk mitigation strategies may also be 
possible to control HT volunteers and wild species.  It would appear that France is 
now convinced that if HT volunteers or wild species occur that they can be detected 
rapidly enough and eliminated."52  
51. Dr. Squire similarly concluded that "[t]he ri sk management options were and are similar to 
those indicated generally for oil seed rape at Responses 6d and 101."53  
 
                                                      
50 Nutti Response, Question 58.   
51 Dr. Marilia Regina Nutti's Answers to Questions to E xperts,  Q. 60.  See also Dr. Nutti's responses to 
questions 59 and 61 in which she concludes that adequate information was available to allow France to assess 
the risks to human and animal health. 
52 Andow Response, Question 61. 
53 Dr. Squire's Answers to Questions to Experts  Q. 61, p. 15.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-23 
 
 
  52. As a final point, the United States notes that the EC has not even attempted  to explain how 
this measure falls within th e parameters of Article 5.7.54
 
Topas 19/2 (notification C/UK/95/M5/1)
 
French Safeguard Measure  (Questions 62-66)  
 
53. The experts' advice provides unanimous confirmation that the scientific evidence presented by 
the EC fails to demonstrate that the French safe guard measure is consistent with the relevant SPS 
disciplines.   
 
54. The experts unanimously confirmed that the findings of the UK farm scale evaluation study 
were not relevant to evaluating this application for import and processing of this notification, and 
therefore, provided no scientific support for a prohibition on the import and processing of these 
oilseed rape seeds.55  
 
55. The experts further confirmed that the av ailable information provides no support for the 
French measure on the basis of any  human or an imal health risk.  As Dr. Nutti explained,  
 
"[T]he scientific evidence submitted by France does  not support a temporary 
prohibition on the import and processing of oilseed rape Topas 19/2."56
56. Nor did the experts believe that the availabl e information was insufficient to permit either 
member State to evaluate the potential risks to hum an or animal health.  Dr. Nutti explains that: 
"Based on the information presented by the notifiers  and by the evaluation of SCP, my understanding 
is that there is NO reason to believe that the sci entific evidence available to France in November 1998 
and July 2001 was NOT sufficient to permit it to undertake an appropriate assessment of potential risks to human, plant and anim al health, and the environment from the import and processing of 
oilseed rape Topas 19/2."
57
 
57. The experts also confirmed that the justification the member State offered to support the 
temporary prohibition had no scientific support.  W ith respect to the French measure, Dr. Snow 
concluded that:  
 
                                                      
54 As the United States has previously stated, while the scientific experts can provide advice on specific 
scientific questions, they cannot be called upon to develop their own arguments, or otherwise speculate as to 
why a safeguard measure is consistent with the obligati ons under the SPS Agreement.    Experts can provide a 
panel with vital perspectives, information, and advice on scientific and technical issu es, but this advice cannot 
substitute for the risk assessment required by Article 5.1 of the SPS Agreement.  Nor is such advice sufficient to demonstrate that a measure falls within the parameters of Ar ticle 5.7.   For example, in  this specific case, the EC 
has not identified any available pertinent information upon which the safeguard might be based; the EC has not explained how the information was insufficient for a risk assessment when the EC's own scientific committee completed a risk assessment; the EC has not shown that  France "sought the information necessary for a more 
objective assessment of the risk," and the EC has not sh own that France reviewed its  ban "within a reasonable 
period of time."  These same points regarding the respec tive roles of disputing Parties and scientific experts 
applies equally to all of the member State safeguard measures.   
55 Dr. Andow's Answers to Questions to Experts, para 62.01; Dr. Squire's Answers to Questions to 
Experts; Q. 62;  Dr. Allison Snow's Answers to Questions to Experts; Q. 62, p. 24. 
56 Dr. Marilia Regina Nutti's Answers to Questions to Experts; Q. 65. 
57 Dr. Marilia Regina Nutti's Answers to Questions to Experts; Q. 63 WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-24 
  
                                                       "I did not find any convincing arguments for why further scientific research would be 
needed to investigate environmental eff ects of a product that is only intended for 
import and processing and not for cultivation."58
58. Similarly, Dr. Andow  concluded that "[ t]he scientific evidence and other information 
submitted by France does not support the adoption of a temporary prohibition on the import and 
processing of oilseed rape Topas 19/2."59  He explained as follows:   
 
"63.03.  The argument used by France that  was based on spatial scale does not hold 
for this case.  With importation and processi ng, it is highly unlikely that large-scale 
production of GMHT oilseed rape is possible.   Thus, the data on small-scale dispersal 
is probably sufficient to complete a risk assessment even in 1998. 
63.04.  Moreover, the hazard of widespread HT resistance in oilseed rape or related wild species does not hold for this case.  Th is hazard is also scale-dependent, and 
with the small-scale releases and poor surv ival expected in spillage and other 
accidental releases, it is not feasible that th is hazard will occur.  Even if it were 
possible (see paragraph 62.01), there would many, many other possible ways to manage this risk short of a prohibition.  Thus, the rationale stated by France does not 
argue that a risk exists that requires management."
60
59. Although one expert attempted to suggest ra tionales on which France might have relied to 
support the safeguard measure,61 the EC did not rely on these ratio nales and the EC has not explained 
them.  In addition, this same expert goes on to not e that France did not seek to obtain the additional 
information necessary for a more objective assessment of the risk.  Dr. Andow explains:   
 
"However, I believe that had France collected the necessary data to complete this risk 
assessment promptly after implementing their temporary prohibition that they could 
have had sufficient data to make a decision in 2001."62
Greek Safeguard Measure  
 
60. The experts unanimously confirmed that the findings of the UK farm scale evaluation study 
were not relevant to evaluating the application for import and processing of this notification, and 
therefore, provided no scientific support for a prohibition on the import and processing of these 
oilseed rape seeds.63   
 
61. The experts further confirmed that the ava ilable information did not identify a human or 
animal health risk that would support the Gr eek safeguard measure.  Dr. Nutti explained: 
 
 
58 Dr. Allison Snow's Answers to Questions to Experts; Q. 62-66, pp. 24.- 
59  .Dr. Andow's Answers to Questions to Experts, paras. 63.01  p. 
60  Dr. Andow's Answers to Questions to Experts, pa ras.  63.03-63.04; see al so Andow Answers to Q. 
64 and 65. 
61 E.g., Dr. Andow's Answers to Questions to Experts, paras 63.05 and 65.01. 
62   Dr. Andow's Answers to Questions to Experts, paras 63.07. 
63 Dr. Andow's Answers to Questions to Experts, para 62.01; Dr. Squire's Answers to Questions to 
Experts; Q. 62;  Dr. Allison Snow's Answers to Questions to Experts; Q. 62, p. 24.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-25 
 
 
  "[T]he scientific evidence submitted by Greece does  not support a temporary 
prohibition on the import and processing of oilseed rape Topas 19/2."64
62. Nor did the experts believe that the availa ble information was insufficient for Greece to 
evaluate the potential risks to human or animal health.  Dr. Nutti explained:   
 
"[A]ll the information for the safety assess ment of potential risks to human and 
animal health that was submitted by the a pplicants and evaluated by UK and SCP was 
adequate and in accordance to the C odex Guidelines (FAO/WHO Codex Principles 
for the Risk Analysis of Foods Derived from Modern Biotechnology; FAO/WHO Codex Guideline for the Conduct of Food Sa fety Assessment of Foods Derived from 
Recombinant-DNA Plants; FAO/WHO Codex Annex on Possible Allergenicity Assessment)."
65
63. The advice from the experts also confirms th at environmental concerns would not justify the 
measure.  Dr. Snow concluded that  
 
"I did not find any convincing arguments for why further scientific research would be needed to investigate environmental eff ects of a product that is only intended for 
import and processing and not for cultivation. The specific arguments provided by Greece seem flawed.  I do not understand why Greece assumes that feral populations 
would become established or why they would cause environmental problems.  Even if such populations become established, there is  no scientific reason to expect that gene 
flow could harm the genetic diversity or abundance of wild relatives of oilseed rape in Greece."
66
64. Although one expert attempte d to suggest rationales that Greece might have cited to support 
the safeguard measure,67 the EC did not rely on these rationales nor has the EC explained them.  In 
any event, the same expert concl udes that the current state of scientific knowledge would not support 
the Greek safeguard: " Even on these grounds, the temporary prohibition probabl y could not be 
justified past 2001. "68
 
65. In addition, the same expert also concludes that instead of a total product ban, other, less 
drastic risk management measures were available to meet those concerns.  In his advice, Dr. Andow states his view that such alternatives existe d in 1998, and are currently available:   
 
"Several other risk management options [t han the temporary prohibition] could have 
been justified in November 1998.  Risk management strategies include risk 
avoidance, risk mitigation, and risk to lerance.  In 1998 mitigation and tolerance 
strategies were probably inappropriate.  A nother risk avoidance strategy would have 
been to request additional molecular ch aracterization data and allow limited 
importation with attendant monitoring so that the practical aspects of controlling 
escapes from spillage could experienced. 
                                                      
64 Dr. Nutti's Answers to Questions to Experts; Q. 65. 
65 Dr. Nutti's Answers to Questions to Experts; Q. 68 
66 Dr. Allison Snow's Answers to Questions to Experts; Q. 66 
67 Dr. Andow's Answers to Questions to Experts;  paras 66.05 and 68.01 
68  Dr. Andow's Answers to Questions to Experts; para 68.01 (emphasis added). WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-26 
  
  These options were available in 2001 and remain today.  In addition risk mitigation 
strategies may also be possible to control HT volunteers and wild species."69   
66. Finally, Dr. Andow notes that if Greece had in  fact been concerned with such environmental 
issues, it had more than sufficient time to gather  the necessary information to assess them, but Greece 
failed to do so:  "I believe that had Greece collected the necessary data to complete this risk assessment promptly after implementing their te mporary prohibition that they could have had 
sufficient data to make a decision in 2001."
70
 
Maize Bt-176 (notification C/F/11-03)
 
Austrian Safeguard measure (Questions 69-71)  
 
67. The expert advice confirmed that Austria's reliance on potential risks to human and animal 
health from the bla  gene conferring ampicillin resistance as a ju stification for its safeguard measure is 
not supported by the scientific evidence.  As Dr. Nutti explained,  
 
"Based on the information presented by the notifiers and by the evaluation of four 
different scientific committees, my understandi ng is there is NO reason to believe that 
the scientific evidence availabl e to Austria in February 1997 was NOT sufficient to 
permit it to undertake an appropriate assessme nt of potential risks to human, plant 
and animal health, and the environment from the importation and use of Maize Bt-
176.71
As far as my knowledge goes, concerning food safety and nutrition, the scientific 
evidence submitted by Austria does not supp ort a temporary prohibition on the import 
and use of Maize Bt-176. 
In EC-144, Austrian Contribution for the WTO-Dispute-Expert-Meeting of the  European Commission 14 January 2004 in Brussels,  I found that Austria presents 
also issues related to allergenicity and toxicological risk assessment, but I cannot 
agree with the points raised, as they are not in accordance with the FAO/WHO Codex 
Guideline for the Conduct of Food Safety Assessment of Foods Derived from 
Recombinant-DNA Plants; FAO/WHO Codex Annex on Possible Allergenicity 
Assessment."
72  
68. Although one expert attempted to  offer rationales that the EC mi ght have raised to support the 
safeguard measure,73 the EC has not relied on these rationales nor has the EC explained them.  
Further, the same expert also concludes that instead of a total product ban, other, less drastic risk 
management measures were available to meet any su ch concerns.  Dr. Andow makes clear that such 
alternatives existed in 1999, and are currently available:   
 
"Other risk management options could not have been justified in February 1997.  
However, had Austria worked to develop its own acceptable resistance management 
measures, perhaps by 1999 other risk manage ment options would have been possible.  
                                                      
69 Dr. Andow's Answers to Questions to Experts; paras 68.02-68.03. 
70  Dr. Andow's Answers to Questi ons to Experts; para 66.05. 
71  Dr. Nutti's Answers to Ques tions to Experts;  Q.69. 
72  Dr. Nutti's Answers to Ques tions to Experts;  Q. 71. 
73  Dr. Andow's Answers to Questions to Experts; paras 69.16, and 71.03--71.04.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-27 
 
 
                                                       Today several alternative risk management options are available.  Risk management 
strategies include risk avoidance, risk m itigation, and risk tolerance.  Tolerance 
strategies are probably inappropriate.  One a lternate risk avoidance strategy would be 
to implement country-specific resistance ma nagement measures, to limit planting to a 
restricted region, and to conduct intensive non-target experiments.  This would allow progressive determination of non-target effects."
74  
German Safeguard measure (Questions 72-74)   
 
69. The expert advice confirmed that Germany's reliance on potential risks to human and animal 
health resulting from the presence of an antibiotic r esistance marker gene as a justification for its 
safeguard measure is not supported by the scientific evidence.  As Dr. Nutti stated, 
 
"As far as my knowledge goes, regarding food safety and nutrition issues, the 
scientific evidence submitted by German y does not support a temporary prohibition 
on the import and use of Maize Bt-176."75
70. The expert advice also makes clear that even if some risk had been identified, measures short 
of a wholesale ban  existed in 2002, and are currently available.  Dr. Andow explained: 
 
"Other risk management options could not have been justified in March 2000.  However, had Germany worked to develop its own acceptable resistance management 
measures, perhaps by 2002 other risk manage ment options would have been possible.  
Today several alternative risk manageme nt options may be available.  Risk 
management strategies include risk avoidance,  risk mitigation, and risk tolerance.  
Tolerance strategies are probably inappropriate .  One alternate risk avoidance strategy 
would be to implement country-specific r esistance management measures, to limit 
planting to a restricted region, and to conduc t intensive non-target experiments.  This 
would allow progressive determination of non-target effects."76  
Luxembourg Safeguard measure (Questions 75-77) 
 
71. The expert advice confirmed that Luxembour g's reliance on potential human health risks  
resulting from the presence of an antibiotic resistance marker gene as a justification for its safeguard measure is not supported by the scientific evidence.  As Dr. Nutti stated, 
 
"Based on the information presented by the notifiers and by the evaluation of four different scientific committees, my understandi ng is there is NO reason to believe that 
the scientific evidence available to Luxembourg in February 1997 was NOT 
sufficient to permit it to undertake an appr opriate assessment of potential risks to 
human, plant and animal health, and the e nvironment from the importation and use of 
Maize Bt-176.
77
 
74  Dr. Andow's Answers to Questions to Experts; paras  71.03 and 71.04. 
75  Dr. Nutti's Answers to Ques tions to Experts;  Q. 74. 
76   Dr. Andow's Answers to Questions to Experts; paras  74.03-74.04. 
77 Dr. Nutti's Answers to Questions to Experts; Q. 75. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-28 
  
  As far as my knowledge goes, regarding food safety and nutrition issues, the 
scientific evidence submitted by Luxembourg does not support a temporary 
prohibition on the import and use of Maize Bt-176."78
72. Although one expert attempted to  offer rationales that the EC mi ght have raised to support the 
safeguard measure,79 the EC did not rely on these rationales nor has the EC explained them.  
Moreover, the same expert concluded that alterna tives to a total ban existed potentially as early as 
1999, and are currently available.  Dr. Andow explained: 
 
"Other risk management options [than th e temporary prohibition] probably could not 
have been justified in February 1997.  However, Luxembourg could have proposed 
its own acceptable resistance monitoring measures, which perhaps by 1999 would have been possible to implement.  
Today several alternative risk management  options are available for monitoring for 
resistance.  Although there is still no scientific consensus around the best monitoring method, the cost-efficiency trade-offs ar e known, and considerable experience has 
accumulated so that several can be feasibly implemented."
80  
Maize Mon 810 (notification C/F/95/12-02)
 
Austrian safeguard measure (Questions 78-80)  
 
73. The expert's advice confirmed that the scientific evidence does not support the existence of any human or animal health risk that would jus tify Austria's safeguard measure.  Dr. Nutti concluded 
that  
 
"Based on the information presented by notif iers and by the scientific evaluation 
undertaken by France and by SCP, my understanding is there is no reason to believe that the scientific evidence av ailable to Austria in June 1999 was NOT sufficient to 
permit it to undertake an appropriate assessme nt of potential risks to human, plant 
and animal health, and the environment from the importation and use of Maize MON 810.
81
As far as my knowledge goes, the scientific evidence submitted by Austria does not support a temporary prohibition of the import and use of Maize MON 810."
82   
74. Although one expert suggested rationales that the EC might have raised to support the safeguard measure,
83 the EC did not rely on these rationales nor has the EC explained them.  In 
addition, the same expert concludes that alternatives to a total product ban are likely to be available.  
Dr. Andow explains: 
 
"Other risk management options [than th e temporary prohibition] may have been 
justified in June 1999.  Because the full resistance management and monitoring 
                                                      
78 Dr. Nutti's Answers to Questions to Experts;  Q. 77. 
79 Dr. Andow's Answers to Questions to Experts; paras 75.09 and 75.12. 
80 Dr. Andow's Answers to Questions to Experts; paras 77.02-77.04. 
81 Dr. Nutti's Answers to Questions to Experts; Q. 78. 
82 Dr. Nutti's Answers to Questions to Experts; Q. 80. 
83 Dr. Andow's Answers to Questions to Experts; paras 78.05-78.06.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-29 
 
 
  measures were not before the Panel, the sci entific basis for a concrete discussion of 
this is not possible.  
Today several alternative risk manageme nt options may be available.  Risk 
management strategies include risk avoidance,  risk mitigation, and risk tolerance.  
Tolerance strategies are probably inappr opriate.  Because the full resistance 
management and monitoring measures were not  before the Panel, the scientific basis 
for a concrete discussion of this is not possible."84
Italian safeguard measure (Questions 81-83) 
 
75. The advice from the experts confirms that the scientific evidence does not support Italy's 
safeguard measure with respect to Maize MON 810.   
 
"My opinion is that the Italian CA did not provide any scientific information that 
could change the evaluations done by the sci entific committees (Food and Plant). It is 
important to point out that the information submitted by the applicant, covered all the 
items needed for the comparison of the GM  maize and its conve ntional counterpart, 
not only with data on nutrients but also with animal feeding studies. The variation in 
levels of protein was in the range of natu ral variation, so the point raised by Italy 
referring to protein was not correct. 
I do not agree with opinion of the Italian CA regarding the ambiguity of the term "substantial equivalence", that, this concep t could be defined differently, given the 
lack of clarity in the Community legislati on.  The way to proceed for the comparison 
between the GM and non GM has been  presented not only at the Community 
legislation but also at the OECD consensus documents, FAO/WHO Expert 
Consultations 1996, 200, 2001 and Codex Alimentarius Guidelines.  
My understanding is there is NO reason to  believe that the scientific evidence 
available to Italy in August 1988 was NOT sufficient to permit it to undertake an 
appropriate assessment of potential risks to human, plant and animal health, and the 
environment from ... Maize MON 810."85  
76. Taking this advice into account, it is clear that the scientific evidence does not support a 
finding that the Italian safeguard measure is  based on legitimate scientific concerns.  
 
Maize T25 (notification C/F/95/12-07)
 
Austrian safeguard measure (Questions 84-86)  
 
77. The expert advice confirms that the scientif ic evidence provided by the EC does not support 
the Austrian safeguard measure.  The only support for the measure is found in the statement made by 
one of the experts that scientific information did exist at the time the measure was adopted that might  
justify the measure.   
 
 
                                                      
84 Dr. Andow's Answers to Questions to Experts; paras 80.03-80.04. 
85 Dr. Nutti's Answers to Questions to Experts;  Q. 81. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-30 
  
                                                       "The adoption of a temporary prohibition was probably not justified on the basis of 
the scientific evidence and other information submitted by Austria.  Austria needed to 
clarify the rationale and provide substa ntial scientific evidence.  A temporary 
prohibition probably could have been justif ied at the time because the appropriate 
scientific information did exist."86
78. However – even if an SPS measure could be justified based on reasons not put forward by the 
member State (nor by the EC) – othe r conclusions of this e xpert make clear that alternatives existed in 
2000, and are currently available, to manage the risks that might have been of concern to Austria.   
 
"Several other risk management options could also have been justified in April 2000.  Risk management strategies include risk avoidance, risk mitigation, and risk tolerance.  In 2000 mitigation and tolerance strategies were probably inappropriate.  Here I consider only the resistance risk.  One risk avoidance strategy would have 
been to allow limited planting in a restricted  region.  This would allow observing how 
T25 would be used and enable assessment  of the selective pressure on weeds.  
Another approach would have been to limit use on any particular field to once every 
4-5 years.  This would reduce selection pressure for a long time, allowing alternative management measures to be developed." 
Italian safeguard measure (Questions 87-89) 
 
79. The advice from the experts confirms that the scientific evidence does not support Italy's 
safeguard measure with respect to Maize T25. 
 
"My opinion is that the Italian CA did not provide any scientific information that 
could change the evaluations done by the sci entific committees (Food and Plant). It is 
important to point out that the informati on submitted by the applicant covered all the 
items needed for the comparison of the GM  maize and its conve ntional counterpart, 
not only with data on nutrient but also with animal feeding studies. The variation in 
levels of protein was in the range of natu ral variation, so the point raised by Italy 
referring to protein was not correct. 
I do not agree with opinion of the Italian CA regarding the ambiguity of the term 'substantial equivalence', that this concept could be define d differently, given the lack 
of clarity in the Community legislation.  The way to proceed for the comparison between the GM and non GM has been  presented not only at the Community 
legislation but also at the OECD consensus documents, FAO/WHO Expert 
Consultations 1996, 200, 2001 and the Codex Alimentarius Guidelines. 
My understanding is there is NO reason to  believe that the scientific evidence 
available to Italy in August 1988  was NOT  sufficient to permit it to undertake an 
appropriate assessment of potential risks to human, plant and animal health, and the 
environment from GM maize T25."87
80. Taking this advice into account, it is clear that the scientific evidence does not support the 
adoption of this safeguard measure.   
 
 
86 Dr. Andow's Answers to Questions to Experts; paras 86.0. 
87 Dr. Nutti's Answers to Questions to Experts; Q. 87.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-31 
 
 
  Maize Mon 809 (notification C/F/95/12-01/B)
 
Italian safeguard measure (Questions 90-92)  
 
81. The advice from the experts confirms that the scientific evidence does not support Italy's 
safeguard measure with respect to Maize Mon 809.   
 
"My opinion is that the Italian CA did not provide any scientific information that 
could change the evaluations done by the sci entific committees (Food and Plant). It is 
important to point out that the information submitted by the applicant, covered all the 
items needed for the comparison of the GM  maize and its conve ntional counterpart, 
not only with data on nutrient but also with animal feeding studies. The variation in 
levels of protein was in the range of natu ral variation, so the point raised by Italy 
referring to protein was not correct. 
I do [not] agree with the opinion of the Italian CA regarding the ambiguity of the term 'substantial equivalence', that this c oncept could be defined differently, given the 
lack of clarity in the Community legislati on. The way to proceed for the comparison 
between the GM and non GM has been  presented not only at the Community 
legislation but also at the OECD consensus documents, FAO/WHO Expert 
Consultations 1996, 200, 2001 and the Codex Alimentarius Guidelines. 
My understanding is there is NO reason to  believe that the scientific evidence 
available to Italy in August 1988  was NOT  sufficient to permit it to undertake an 
appropriate assessment of potential risks to human, plant and animal health, and the 
environment from GM maize MON 809."88  
82. Taking this advice into account, it is clear that the scientific evidence does not support the 
adoption of this safeguard measure.   
 
Maize Bt-11 (reference C/GB/96/M4/1)
 
Italian safeguard measure (Questions 93-95) 
 
83. The advice from the experts confirms that the scientific evidence does not support Italy's 
safeguard measure with respect to Maize Bt-11.   
 
"My opinion is that the Italian CA did not provide any scientific information that could change the evaluations done by the sci entific committees (Food and Plant). It is 
important to point out that the information submitted by the applicant, covered all the 
items needed for the comparison of the GM  maize and its conve ntional counterpart, 
not only with data on nutrient but also with animal feeding studies. The variation in 
levels of protein was in the range of natu ral variation, so the point raised by Italy 
referring to protein was not correct. 
I do not agree with the opinion of the Italia n CA regarding the ambiguity of the term 
'substantial equivalence', that this concept could be define d differently, given the lack 
of clarity in the Community legislation.  The way to proceed for the comparison 
between the GM and non GM has been  presented not only at the Community 
                                                      
88 Dr. Nutti's Answers to Questions to Experts; Q. 90. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
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  legislation but also at the OECD consensus documents, FAO/WHO Expert 
Consultations 1996, 200, 2001 and the Codex Alimentarius Guidelines. 
My understanding is there is NO reason to  believe that the scientific evidence 
available to Italy in August 1988  was NOT  sufficient to permit it to undertake an 
appropriate assessment of potential risks to human, plant and animal health, and the 
environment from GM maize Bt-11."89  
84. Taking this advice into account, it is clear that the scientific evidence does not support the 
adoption of this safeguard measure. 
 
D. ADDITIONAL QUESTIONS  
General Questions
 
Question 110.  On the basis of the information be fore the Panel, is there any scientific evidence 
to support the hypothesis that animal feed made from biotechnology plants alters the 
composition of the food derived from animals consuming the feed?    
 
(a) If so, what is the likelihood that this event could lead to adverse effects on human or 
animal health?  (see, inter alia, exhibit US-144)  
 
(b) What risk management options are available to mitigate any resulting risks and what is 
their efficacy? 
 
85. Dr. Nutti's response supports the US position: "I  am not aware of any scientific evidence that 
supports the hypothesis that animal feed made from biotechnology plants alters the composition of the 
food derived from animals consuming the feed."90  Dr. Nutti also cites several scientific papers 
showing no compositional changes in food derived from animals that consumed biotech animal feeds.   
 
Question 112.  Please provide an assessment of the statements regarding chronic toxicity testing 
in paragraph 43 of Canada's Third Submission and paragraphs 134-138 of the US Supplementary Rebuttal Submission.  What relevance does the foreseen end product use(s) 
have in the context of the evaluation of the toxicity of that product?  
 
86. Dr. Nutti agrees with the scientific position put forth by the United States:  
 
"As I had pointed out in several answers, and based on the Codex Alimentarius Guidelines for the Conduct of Food Safety Assessment of Foods Derived from 
Recombinant-DNA Plants (CAC/GL 45-2003), paragraphs 34 to 43, Assessment of 
Possible Toxicity, we have at paragraph 37 that the use of appropriate conventional toxicology or other studies on the new substance may be necessary if, taking into account its function and exposure,  doubts about the safety of the new substance 
remain. My understanding is that if the toxicological assessment has conducted acute 
gavage studies in mice, homology to known toxins and allergens  with no indication 
of adverse effects, chronic toxicity tests  shall not be required."
91
                                                      
89 Dr. Nutti's Answers to Questions to Experts; Q. 93. 
90 Nutti Response, Answer 110.   
91 Nutti Response, Answer 112.    WT/DS291/R/Add.7 
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  Question 113.  Please provide an assessment of th e statements regarding the purpose and use of 
whole food studies in paragraphs 142-144 of th e US  Supplemental Rebuttal Submission.  What 
relevance does the foreseen end product use(s) have in the context of using whole food studies in 
the evaluation of the safety of that product? 
 
87. Dr. Nutti agrees with the scientific position expressed by the United States:  
 
"My understanding is that if the comparison of the composition of the GM product and its conventional counterpart has shown to  be substantially equivalent, the 90-day 
oral study and at least one more feeding st udy (usually 48 day broiler chicken) has 
provided information on the consumption of the whole food, the request for multiple 
whole food studies in different species does not have scientific support."
92
Product-Specific Questions  
 
Monsanto Roundup Ready corn (NK603), C/ES/00/01  (EC chronology 76)  
 
Question 39bis:  Given the information before the Panel, including the notification and 
additional letter from Monsanto providing additional information (previously referenced and EC-76/At.11-12), was additional information regarding allergenicity studies and PCR tests 
requested by Austria (EC-76/At.44) necessary or u seful to ensure that conclusions of the safety 
assessment were valid? 
 
88. Dr. Nutti agrees with the US  view that the additional info rmation requested by Austria was 
not needed for a safety assessment:  
 
"Based on EC-76/At.11-12 and the request by the lead CA in EC-76/At.44, regarding 
to allergenicity studies and PCR tests, my opinion is that such a request was not 
necessary to ensure that conclusions of the safety assessment were valid."93   
Monsanto Roundup Ready corn (GA 21), C/ES/98/01 (EC chronology 78), C/GB/97/M3/2  (EC 
chronology 85)  
 
Question 40bis:  Given the information before the Panel, including the first whole food study and agronomic performance tests (attached, cover letter provided in EC 78/85/At. 19), was a 
second animal whole food study requested by Denmark, Austria and Italy (EC-78/85 /At. 67, 40 and 72) necessary or useful to identify potential adverse effects that had not been previously 
identified?  
 
89. Dr. Nutti, citing Codex guidelines, agrees with  the United States that a request for "a second 
animal whole feeding study" was not needed for a food safety assessment.94  
 
Monsanto MaisGard Roundup Ready (MON 810 & GA21) corn (stack), C/ES/99/02  (EC 
chronology 94)  
 
Question 44bis:  Given the information before the Panel, including the first whole food study 
and agronomic performance tests (EC 94/At.3, pp. 40), was a second animal whole food study 
                                                      
92 Nutti Response, Answer 113.   
93 Nutti Response, Answer 39bis. 
94 Nutti Response, Answer 40bis.   WT/DS291/R/Add.7 
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  (EC 94/At.12) necessary or useful to identify po tential adverse effects, including those associated 
with small random DNA insertions, that had not been previously identified? 
 
90. Dr. Nutti agrees with the position expressed by th e United States, stating her "opinion is that 
such a request was not necessary to ensure that conc lusions of the safety assessment were valid."    
 
Question 44ter:  In the context of this corn pr oduct which was produced through conventional 
breeding from biotech parents, is data regarding the safety of the biotech parent plants relevant 
to the safety assessment of the hybrid plant pro ducts?  Given the results of the risk assessment 
studies of the biotech parents, were additional studies necessary or useful to ensure that the 
conclusions of the safety assessment relate d to the hybrid plants were valid?    
 
91. Dr. Nutti agrees with the position of th e United States.  She explains that  
 
"In this case I believe that given the results of the risk assessment studies of the biotech parents, no additional studies were necessary or useful to ensure that the 
conclusions of the safety assessment relate d to the hybrid plants were valid."
95
Monsanto Roundup Ready corn (NK603), (EC chronology 96)  
 
Question 53bis:  Given the information before the Panel, including the first whole food study and agronomic performance tests (EC 96/At.2 , pp. 102-103), was a second animal whole food 
study (EC 96/At. 7) necessary or useful to iden tify potential adverse effects, including those 
associated with small random DNA insertions, th at had not been previously identified ? 
 
92. Dr. Nutti agrees with the position of the United States.  Citing to Codex standards, Dr. Nutti 
states that "such a request [for a second animal whole food study] was not necessary to ensure that conclusions of the safety assessment were valid."
96    
 
                                                      
95 Nutti Response, Answer 44ter.   
96 Nutti Response, Answer 53bis.    WT/DS291/R/Add.7 
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 ANNEX I-2 
 
COMMENTS BY CANADA ON THE REPLIES BY THE 
SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL 
31 JANUARY 2005 
 
 
INTRODUCTION 
 
1. Canada is pleased to have this  opportunity to comment on the answers given by the experts to 
the Panel's questions.  The experts undoubtedly had a difficult task before them, and Canada 
expresses its appreciation to them for their willingness to undertake this task, and for the laudable 
effort that they have made to  respond to the Panel's questions. 
2. Canada's comments on the responses to the Panel's questions provided by Drs. Andow, Healy, 
Nutti, Snape, Snow and Squire are submitted with  a view to assisting the Panel in understanding 
Canada's position on the specific matters addressed by the experts.  Canada's comments do not note 
each and every instance where it agrees with the experts.  Rather, they seek to identify where the experts agree, point out what Canada considers to  be inconsistencies among the experts' responses and 
confirm which position Canada suppor ts, elaborate on some of the r esponses that Canada believes 
require clarification or amplification, and res pond to assertions with which Canada disagrees.   
3. Canada is also pleased to note that, overall, th e answers provided by the experts are consistent 
with Canada's views and positions on the scientific issues raised by the Panel's questions.  The advice 
provided by the experts indicates, for the most part , that little or no  scientific evidence exists with 
respect to risks to human, animal or plant life or heal th, or to the environment, to justify the, in many 
cases inordinate, delays by the European Communities (EC) with respect to the approval of a host of 
biotech product applications.  Similarly, the answers of the experts reinforce the scientific validity of 
Canada's position that the EC Member State prohibitions on approved biotech products of interest to Canada have no scientific basis.  They are not suppor ted by evidence demonstrating a risk, either from 
a food and feed standpoint, or in relation to th e environment, nor can they be justified on 
precautionary grounds. 
4. Canada also draws the Panel's attention to the f act that some of the experts occasionally stray 
beyond their respective spheres of competence in responding to the Panel's questions.  In addition, in some areas, the experts express views on issues that  do not fall within the scope of the Panel's 
questions, either because the issues are not scientific  in nature, or because th e answers, while science-
oriented, go beyond the ambit of the question.  Th is leads some of the experts to engage in 
unwarranted speculation in a number of places.  Ca nada trusts that the Panel will disregard these 
aspects of the experts' replies in so far as they cannot  assist the Panel in resolving the issues before it. 
5. For example, some of the experts express their views on Canada's regulatory regime for 
approving the environmental release of agricultural bi otech products.  In this regard, Canada is bound 
to note that: (1) none of the experts have provide d any indication that they are thoroughly familiar 
with Canada's regulatory regime; (2) the characteriza tion of Canada's regulator y regime by the experts 
is inaccurate in important respects; and (3) Canada's regulatory regime is not in issue in this proceeding nor is it relevant to the questions that ha ve been asked of the experts.  If the Panel believes 
it to be necessary to develop a greater understanding of Canada's regulatory regime in order to make 
its findings in this dispute, Cana da would be pleased to provide a dditional information in order to 
enhance that understanding, and to correct the inaccuracies found in the opinions of some of the 
experts. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
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 6. Canada takes this opportunity to observe that  some of the experts' answers question or 
challenge the analyses and conclusions of the re levant European Communities scientific committees 
directly.  It is unfortunate that the members of these committees are unlikely to be present at the 
hearing or to have an opportunity to respond to the experts' observations in this regard. 
7. More generally, Canada is compelled to emph asize that the current proceedings depart from 
previous SPS-related disputes in that the scientific opinions of the responding party are not being 
challenged by the complainants; to the contrary, it is the respondent that seeks to minimize their impact on the outcome of the proceedings.  In this context, it is useful to recall that it is not the 
function of either the Panel's scientific advisors or the Panel itself to conduct a de novo  examination 
of the scientific assessments that have been conducted by the relevant Member State Competent 
Authorities, the Community scientific committees or th e European Food Safety Authority.  Rather, it 
is for the EC and its Member States to show that  they have based their measures on scientific risk 
assessments, and that if they have chosen to disregard the scientific opinions of the Community 
scientific committees, they did it on the basis of other, more compelling risk assessments.  The EC has 
not offered any concrete evidence that this is the case. 
8. In this submission, Canada comments on the e xperts' answers to the following questions only: 
Q1-9 (General Questions); Q14-20 (oilseed rape Ms8xRf3); Q26-28 (oilseed rape GT73); Q59-68 and 
Q81-95 (safeguard measures except those pertaining to maize Bt-176 and Austria's prohibition on MON810); Q96-106 (General Questions); and Q1 10 and 112 (Additional Questions).  However, 
Canada reserves its right to comment on the experts'  answers to any of the other questions at the 
meeting with the experts.  Canada also reserves its right to comment further on the experts' answers in subsequent submissions. 
9. Canada looks forward to meeting with the experts and to the opportunity to discuss the 
scientific issues raised by experts' answers to the Panel's questions in more detail at that meeting. 
General Questions  
 
1. the basis of the information before the Pane l, is there any scientific evidence to support 
the hypothesis that antibiotic resistance marker genes (ARMG) pass from a biotech food or feed product to bacteria or other micro-organisms present in the human or animal gut?   
 
(a) If scientific evidence indicates that such an  event could occur, what risks, if any, 
would arise from that event?  What is the comparative relevance or magnitude of this risk in relation to the likelihood of such a transfer from other sources of antibiotic resistance not involving the use of recombinant DNA technology? 
(b) If such risks have been identified, what is the likelihood of adverse effects to 
human or animal health, in light of the processing of raw biotech products into 
human food or animal feedstuffs?   
(c) Are these consequences relevant to the specific types of ARMG currently used in the products at issue in this dispute?  Please explain. 
(d) If such risks have been identified, what risk management options are available to mitigate those risks and what is their efficacy?    WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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                                                      10. In her reply to this question, Dr. Nutti stat es that, despite "numerous experiments aimed at 
evaluating the possibility of transfer of plant DNA to microbes and mammalian cells…there are no 
reports that marker genes in plant DNA transfer to these cells."1 
11. Dr. Nutti also says that even if such transfers were to take place for marker genes that confer 
resistance to kanamycin, ampicillin or streptomycin , they are "unlikely to present a significant health 
impact since bacteria resistant to  these antibiotics are already spread  all over or are naturally found in 
the human gastrointestinal tract."2  Finally, and in any event, many of these antibiotics are rarely used 
on humans due to their negative side effects. 
12. Dr. Nutti's conclusions are amply supported by th e literature she referenc es, as well as by 
other sources.3 
13. Dr. Nutti's advice fully supports the argument that  there is no scientific evidence that would 
support a refusal to approve, or to suspend the marketing of, a GM product on the grounds that the 
presence of an antibiotic resistance marker (ABRM)  gene constitutes a risk to human or animal 
health. 
2. On the basis of the information before the Panel, is there any scientific evidence to support the hypothesis that antibiotic resistance develops through ways other than the uptake of 
food or feed by humans or animals, that is, due to the potential persistence of plant-derived DNA in the environment during crop cultivation and harvesting, and in soil residues?   
 
(a) If scientific evidence indicates that such an event could occur, what risks, if 
any, would arise from that event?  What is the comparative relevance or magnitude of this risk in relation to the likelihood of such a transfer from other sources of antibiotic resistance not involving the use of recombinant DNA technology? 
(b) Are these consequences relevant to the specific types of ARMG currently used in the products at issue in this dispute? 
(c) If such risks have been identified, what risk management options are available to mitigate those risks and what is their efficacy? 
14. Although Dr. Squire and Dr. Nutti indicated that they intended to answer this question, their 
reports do not contain answers to it.  Dr. Squire's  report contains no answer at all, and Dr. Nutti 
indicates that she will not answer because the question pertains to "environmental safety". 
15. Nevertheless, in an effort to advance the Pa nel's understanding, Canada notes the existence of 
studies pertaining to this issue.  In addition to the already cited article in the Journal of Antimicrobial 
 
1 Answers to the Panel's Questions from Dr. Marilia Regini Nutti, 6 January 2005, p. 2.  [hereinafter 
Nutti] 
2 Ibid. 
3 See, for example, Bennett, P.M., et al., "An assessment of the risks asso ciated with the use of 
antibiotic resistance genes in genetically modified plants: report of the Working Party of the British Society for 
Antimicrobial Chemotherapy" Journal of Antimicrobial Chemotherapy  (2004) 53, 418-431. (Exhibit CDA – 
172). WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
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                                                      Chemotherapy ,4 published work by Dr. Abigail Salyers5 and Dr. K. Smalla6 indicate that this is a low 
probability event and that it would pose a minimal risk even if it were to occur. 
16. Dr. Salyers provides an extensive theoretical ex amination of the issue, which considers all 
potential mechanisms and refutes most of them as unlikely.  Dr. Smalla has conducted field studies 
that demonstrate that under normal fiel d conditions this event is unlikely, and that even if it were to 
occur it would be at such low frequency that it would pose minimal risk compared to natural 
mechanisms (of gene transfer  between soil pathogens) or any therapeutic use. 
17. Canada requests that the experts provide their comments, if any, on the relevant scientific 
information in these studies to the extent that it falls within their field of expertise. 
3. On the basis of the information before the Panel, is there any scientific evidence to 
support the hypothesis that wide-spread cultivation of Bt crops such as biotech maize of the Bt 
variety adversely affects non-target organisms  which may be exposed to such crops under 
typical agricultural practice?  (See, inter alia , EC-149, EC-150, EC-151, EC-152)  If so, how does 
this risk compare with risks to non-target organ isms arising from non-biotech applications for 
Bt toxins (i.e., the use of Bt toxin as an insecticide in conventional and organic farming)?  What risk management options are available to mitigate any resulting risks and what is their efficacy?  
 
18. Dr. Squire responds to this question by sa ying that current expe rimental evidence is 
insufficient to confirm whether widespread cultivation would affect non-target organisms.  
Importantly, he observes that the weight of evid ence suggests little immediate toxic effect, although 
he also "admits the possibility" of chronic effect s following long-term exposur e.  He concludes that 
the question can only be conclusively answered fo llowing long-term studies and the development of a 
comparator.7 
19. Dr. Squire also points out that any damage to in-field biodiversity can be reversed by rotating 
crops.8  This would suggest that, to the extent that a risk exists, it can be managed relatively easily 
using proven agronomic management practices. 
20. Dr. Andow focuses his comments on the studies found in Exhibits EC-149, EC-150, EC-151, 
and EC 152.  Dr. Andow begins his analysis by st ating that there is some evidence to support the 
hypothesis that wide-spread cultivation of Bt crops  adversely affects non-target organisms but this 
evidence is insufficient to establish the hypothesis that such adverse effects are expected to occur. 
21. Regarding Exhibit EC-149, Dr. Andow looks at the analysis of the studies reviewed in the 
exhibit, and concludes that "there is a possible hazard to collembola [ Folsomia candida ]" but 
concedes that he cannot conclude that there is a po tential risk.  He also concludes that there is a 
 
4 Exhibit CDA-172. 
5 Salyers, Abigail, "Genetically Engineered Foods: Safety Issues Associated with Antibiotic Resistance 
Genes" Alliance for the Prudent Use of Antibiotics  (Exhibit CDA-173). 
6 Smalla , Kornelia et al., "Monitoring the identity and survival of genetically modified or non-modified 
plant growth promoting bacteria and their impact on so il microbial communities" (Paper presented to the 7th 
International Symposium on the Biosafety of Genetically Modified Organisms, Beijing, China October 2002). 
(Exhibit CDA-174). 
7 Answers to Questions 3 to 5 from Dr. Geoff Squire, 6 January 2005, p. 3.  [hereinafter Answers to 
Questions 3 to 5, Squire] 
8 Ibid., p. 2-3.  WT/DS291/R/Add.7 
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                                                      potential risk to C. carnea ".9  However, regarding the the Collembola study, it must be said that it is, 
at best, inconclusive.  Dr. Andow cites no other st udies with respect to this organism that have 
reproduced the results of the study reviewed in th e exhibit, and without further details about that 
study, which, according to Exhibit EC-149, was not pub lished, or a copy of the study itself, Canada is 
not in a position to evaluate its methodological soun dness or the validity of its conclusions.  In fact, 
other studies suggest that the risk of an adverse impact of Bt on Folsomia candida  is negligible. 
22. As for the studies relating to the putative impact of Bt on C. carnea  (Lacewing), Dr. Andow 
neglects to mention that the cited studies have been effectively refuted by more recent work.10   In 
fact, although it may be true, as Dr. Andow indicates, that there have been "numerous" studies – 
disregarding for the moment the indeterminate nature  of the word "numerous" – majority scientific 
opinion is that there is no significant adverse effect , and there has been no observed effect under field 
conditions. 
23. Dr. Andow also notes later in his answer that any risk to Lacewing under field conditions is 
unlikely to be large; according to him, any adverse effect will be subtle and difficult to detect in the 
field.  However, his opinion that there will be any effect at all is largely speculative, and ties into his later statement with respect to the absence of eviden ce of adverse effects: "the US experience [i.e. no 
observed adverse effects] does not imply that th ere are no adverse effects on non-target species."
11   
Of course, it is also true that the US experience cannot in any way be said to represent evidence of such adverse effects so it is not clear how Dr. A ndow's statement can be of assistance to the Panel. 
24. The SCP opinion on the Bt11 application for cultivation in 20 00 took into account some of 
the studies reviewed in Exhibit EC-149 in its an alysis, and the Hilbeck studies in particular.12  The 
SCP evidently did not consider that these studies presented a serious impediment to its conclusion that "there is no evidence to indicate that the placing on the market for cultivation purposes of maize line Bt-11…is likely to cause adverse effects on human health and the environment".
13  The SCP did, 
however, recommend monitoring of the fields to pr ovide reassurance that there are no effects at the 
extended field scale. 
25. The SCP also notes in its opinion that "laboratory feeding studies have not shown toxicity to 
earthworms and at field concentrations to Collembola [ Folsomia candida ]".14  Its finding with respect 
to earthworms appears to contradict the Hilbeck study in Exhibit EC-150, cited by Dr. Andow.  
Although Dr. Andow states that there are other studi es that support Dr. Hilbeck's conclusions with 
respect to earthworms, he provides no references. 
 
9 Answers to the Panel's Questions from Dr. David A. Andow, 6 January 2005, p. 1.  [hereinafter 
Andow] 
10 See, for example, Romeis, Jorg, et al., " Bacillus thuringiensis  toxin (Cry1Ab) has no direct effect on 
larvae of the green lacewing Chrysoperla carnea  (Stephens) (Neuropt era: Chrysopidae)" Journal of Insect 
Physiology  50 (2004) 175-183 (Exhibit CDA-175); Dutton, Anna, et al., "Assessing the risks of insect resistant 
transgenic plants on entomophagous arthropods: Bt-maize expressing Cry1Ab as a case study" BioControl  48: 
611-636,2003 (Exhibit CDA-176). 
11 Andow, p. 4. 
12 EC, Scientific Committee on Plants, Opinion on the submission for placing on the market of 
genetically modified insect resistant and Glufosinate am monium tolerant (Bt-11) maize for cultivation.  Notified 
by Novartis Seeds SA Company (Notification No. C/F/96/05-10) , adopted 30 November 2000, p. 8 (Exhibit 
CDA-84). 
13 Ibid. 
14 Ibid. WT/DS291/R/Add.7 
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                                                      26. In any event, it is also noteworthy that an y adverse effects can, as Dr. Squire advises,15 be 
reversed fairly easily through crop rotation. 
27. Dr. Andow concludes, in paragraph 3.10, "tha t possible hazards have been identified and 
potential risks are evident."16  Although the lack of evidence means that an actual non-target risk 
cannot be fully characterized, he believes that if  the analysis is completed, "there will be a 
documented risk of some Bt maize events to monarch butterflies".17  This latter statement is 
completely speculative.  The vast majority of th e scientific literature on Bt and monarch butterfly 
populations states unequivocally that there is no significant adverse effect on monarch butterfly 
populations under field conditions.18 
28. Bt corn has been grown widely across Canada and the United States for eight years.  Despite 
this fact, there is still no scientific evidence of significant non-target adverse effects under field 
conditions.  If, as Dr. Andow states, that even af ter all this time and widespread environmental 
exposure, no one has observed significant adverse non-target effects, it is quite plausible, and even reasonable, to draw an inference that such significant effects are not occurring.  While such an 
inference must be considered speculative, it is no more, and probably less, speculative than the views 
expressed by Dr. Andow.  And to assert that no effects have been noted because nobody is looking is incorrect.  There are in fact a number of groups  conducting such work, the Canadian Corn Pest 
Coalition being one of them.
19 
4. On the basis of the information before the Panel, is there any scientific evidence to 
support the hypothesis that the wide-spread cultivation of Bt maize or other, non-biotech 
applications of Bt toxins, leads to the emergen ce of Bt-resistant target organisms under field 
conditions?  If so, what risk management options exist to mitigate any resulting risks and what is their efficacy? 
 
29. In his reply, Dr. Squire first notes that the emer gence of pest insect resistance to pesticides 
varies widely from context to context, and depends on a range of factors, such as the exposure to and 
strength (dosage) of the toxin, the movement of insect populations, and the genetics and mating 
system of the insect.20  He observes that resistance to Bt crops  (cotton) has occurred and is influenced 
by the "dose" of toxin delivered to the pest and the genetic nature of the pest, among other factors.21  
However, he suggests that managing the emergence of Bt resistance under field conditions is not 
 
15 Answers to Questions 3 to 5, Squire, p. 2. 
16 Andow, p. 4. 
17 Ibid. 
18 See, for example, Oberhauser, Karen S. et al ., "Temporal and spatial overlap between monarch 
larvae and corn pollen" PNAS , Oct 2001; 98: 11913 – 11918 (Exhibit CDA-178); Pimentel, David S. et al., "Bt 
corn pollen impacts on nontarget Lepidopt era : Assessment of effects in nature" PNAS , July 2000; 97: 8198 – 
8199 (Exhibit CDA-179); Sears, Mark K. et al., " Impact of Bt corn pollen on monarch butterfly populations: A 
risk assessment"  PNAS , Oct 2001; 98: 11937 – 11942 (Exhibit CDA-180); Stanley-Horn, Diane E. et al., 
"Assessing the impact of Cry1Ab-expressing corn pollen on monarch butterfly larvae in field studies"  PNAS , 
Oct 2001; 98: 11931 – 11936 (Exhibit CDA-181); Wraight, C.L. et al., "Absence of toxicity of Bacillus 
thuringiensis  pollen to black swallowtails under field conditions" PNAS , Jul 2000; 97: 7700-7703 (Exhibit 
CDA-182); Zangerl, A.R. et al., " Effects of exposure to event 176 Bacillus thuringiensis  corn pollen on 
monarch and black swallowtail cat erpillars under field conditions" PNAS , Oct 2001; 98: 11908 – 11912 (Exhibit 
CDA-183). 
19 Canadian Corn Pest Coalition  "BT CORN STEWARDSHIP INFORMATION NOW AVAILABLE 
ONLINE" 2003; available online http://www.cornpest.ca/lib/news.cfm?id=9  (Exhibit CDA-184). 
20 Answers to Questions 3 to 5, Squire, p. 3. 
21 Ibid.  WT/DS291/R/Add.7 
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                                                      problematic.  According to Dr. Squire, "the processes involved in Bt resistance and its management 
are generally appreciated by scientists, and mitigat ion strategies that have a strong scientific basis 
have been considered. …Sound scientific knowledge h as been applied to this problem for several 
years".22 
30. Dr. Andow is of the view that the emergence of  resistance cannot be prevented, only delayed, 
and he characterizes Bt resistance in pests as an "environmental risk".  The characterization of the emergence of Bt resistant pests, however, is misleading.  The emergence of resistance largely poses an agronomic management problem for farmers in that it will discourage them from using Bt crops. 
31. Dr. Snow seems to agree that the main issue in the emergence of resistance is the "loss of a 
benefit" rather than the creation of a risk.23  She summarizes the benefits of Bt crops, including 
benefits to workers' health, benefits to populations of non-target and beneficial insects, low toxicity, and agronomic benefits of Bt proteins. 
32. Although Dr. Andow claims that "there is scientific consensus that resist ance to Bt maize is 
inevitable", he concedes that despite eight years of  widespread cultivation throughout North America, 
"it has still not been detected in the field".24  In fact, in contrast to chemical applications of Bt, 
mitigation measures used for Bt crops have delaye d emergence of resistant pests far beyond that 
normally seen with chemical applications.  Hen ce, Dr. Andow's statement that "widespread non-
biotech applications of Bt toxins have resulted in  the Bt-resistant target pests organisms under field 
conditions"25 is not really relevant in this particular context. 
33. It is also important to note that Dr. Andow does not provide any reference to a time horizon.  
It must be taken as a given that, if enough time pa sses, virtually anything can be characterized as 
inevitable.  It is fair to say that very few experts expect Bt crops to remain fully resistant to target pests indefinitely. 
34. As Dr. Squire noted, resistance management measures are available to minimize the 
likelihood of Bt-resistant pest insects emerging.  Dr. Andow summarizes the current thinking around 
the most widely used method, that is the use of refuges, and notes that there is some evidence to 
support the hypothesis that the high dose/refuge strate gy has been effective in delaying the emergence 
of Bt-resistant insect pests.26  In fact, because of on-going debates about optimum refuge size, the 
current refuge sizes are conservative.  In other words, they are probably larger th an they need to be to 
be effective. 
35. In summary, the key points about the possible emer gence of pest resistance to Bt crops seem 
to be the following: 
− in principle, it is taken as a given; 
− however, time frame is variable; 
− effective resistance management measu res are available that can delay it; 
− the science underlying these measures is fairly well understood; 
− to date, no organisms that have evolved resi stance to Bt maize have been found; and 
 
22 Ibid. 
23 Answers to the Panel's Questions from Dr. Allison A. Snow, 6 January 2005, p. 9.  [hereinafter 
Snow] 
24 Andow, p. 6. 
25 Ibid. 
26 Ibid., p. 9. WT/DS291/R/Add.7 
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                                                      − it does not really constitute an environmental risk; it is an agronomic management issue. 
 
5. On the basis of the information before the Panel, is there any scientific evidence to 
support the hypothesis that Bt maize varieties a re any more toxic to humans or animals than 
conventional maize under field conditions?  If so, what risk management options exist to 
mitigate any resulting risks and what is their efficacy? 
 
36. Dr. Squire says assessing product toxicity to ecological processes is more complicated than 
assessing toxicity as a food or feedstuff.  The cont ention that nothing adve rse has occurred when 
growing Bt maize in, say, North America, should not  be taken as definitive evidence by itself that 
nothing will occur in Europe, where the organisms and their interactions are different.  Taken as a 
whole, experiments at the scale of small field plots and one season's exposure indicate no acute 
toxicity to animals other than the pest.  Evidence, either way, of harm to animals arising from growing 
Bt crops in the field in Europe is therefore inconclusive at present.  Longer term studies are needed.27 
37. Dr. Nutti indicates that, based on the information before the Panel, there is no evidence to 
support the hypothesis that Bt maize varieties are more toxic to humans or animals (as feed) than 
conventional maize under field conditions.28 
38. Canada considers that there may be some conf usion as to the scope of this question among the 
experts.  As written, the question can be unders tood as pertaining to Bt toxicity only from the 
standpoint of food and feed.  Conversely, it can be  taken to cover Bt toxicity to animals beyond 
domesticated animals.  Dr. Squire appears to understand the question to be focussing on "ecological processes", noting the added complexities when you go beyond food and feed.  To the extent that the 
focus is ecological rather than food and feed, Ques tion 5 seems to be at least partly repetitive of 
Question 3.  Hence, Dr. Squire notes in parentheses that in some respects his answer repeats his response to the earlier question. 
39. Concerning food and feed, it is noteworthy that  the Scientific Committee on Food (SCF), in 
its 2002 opinion on Bt-11 for food and feed, came to the conclusion that Bt11 sweet maize is as safe for human food use as its conventional counterparts.
29  None of the experts has challenged this 
conclusion. 
6. On the basis of the information before the Panel, is there any scientific evidence to suggest that herbicide tolerant crops (whether biotech or developed through mutagenesis) are 
more persistent in the agricultural environment or more persistent in the non-agricultural environment than their conventional counterparts?  If so, do herbicide tolerant crops qualify as 
a potential "pest" as the term is used in Int ernational Standard for Phytosanitary Measures 
(ISPM) 11?   
 
(a) What is the potential for the establish ment and spread of herbicide tolerant 
plants arising from handling, spillage during transport of the plant/plant parts, or any other means outside of cultivation in the absence of application of the herbicide?  How is any potential fo r establishment and spread affected by 
environmental conditions, the presences of wild or conventional relatives of the 
herbicide tolerant plants in an area, or other factors? 
 
27 Answers to Questions 3 to 5, Squire, p. 4. 
28 Nutti, p. 4. 
29 EC, Scientific Committee on Food, Opinion on a request to place genetically modified sweet maize 
line Bt11 on the market , expressed 17 April 2002 (Exhibit CDA-35-J).  WT/DS291/R/Add.7 
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                                                      (b) What is the potential for the establish ment and spread of herbicide tolerant 
plants in the presence of herbicide app lication (in fields, urban, domestic or 
other environments)?  How is any potential affected by the existence of feral 
related plant species;  infertile wild relatives;  seed survival in relevant 
pedoclimatic conditions;  the reproduction biology of the species;  or other factors? 
(c) Is this potential different for biotech crops tolerant to two wide-spectrum herbicides?  Please explain.  
(d) If significant risks of establishment and spread have been identified, what risk management options exist to mitigate any resulting risks and what is their efficacy? 
(e) What types of post-market monitoring and data collection activities could be envisaged on the basis of the monitori ng and review principles described in 
ISPM 11? 
40. Drs. Snow, Squire and Andow conclude that herbicide tolerant (HT) crops have the potential 
to become "pests", supporting Canada's assertion to that effect.30  Although the crop itself is not 
"injurious to plants or plant products," Annex 3 of  ISPM No. 11 lists potential phytosanitary risks for 
LMOs including changes in adaptive characteristics which may increase the potential for introduction or spread including alterations in "pes ticide (including herbicide) resistance."
31  Drs. Snow and Squire 
conclude that in the absence of herbicide, th e HT crop should be no more persistent in the 
environment than non-HT crops, a conclusion that is  seemingly at odds with Dr. Andow (para. 6.02). 
41. Dr. Andow's view that "GMHT oilseed rape  may be more persistent … than their 
conventional HT oilseed rape" appears to be based  on the fact that the GMHT varieties are more 
commonly used. 
42. Drs. Snow and Squire conclude that the applica tion of an herbicide to an HT plant that is 
resistant to that herbicide would favour that pl ant; consequently the HT plant may become more 
abundant.  The more extensively the herbicide is used the stronger the selection pressure favouring the HT plants.  Thus, whether or not an HT crop is considered a "pest" depends in large part on the extent and nature of herbicide use. 
43. Canada asks that Drs. Squire and Snow clarif y whether this argument would apply equally to 
crops that are naturally  resistant to certain herbicides ( e.g. wheat and barley are naturally resistant to 
fenoxaprop-p-ethyl+safener (PUMA), trialcoxidim, dicolfop-methyl (ACCase mode of action - these herbicides are used throughout Europe to control gras sy weeds in wheat and barley)).  For those crops 
that are naturally  HT, would the application of the herbicide to which they are tolerant confer a 
selective advantage over other plants?  Thus, w ould feral populations of wheat have a selective 
advantage when sprayed repeatedly with fenoxaprop-p -ethyl?  Is a solution to this problem to use a 
different herbicide or mix of herbicides?  Is not  the nature of herbicides to provide a selective 
advantage to certain plants that are resistant to those herbicides? 
 
30 Canada Third Written Submission, para. 73. 
31 ISPM N° 11: Pest risk analysis for quarantine pests, including analysis of environmental risks and 
living modified organism, FAO, April 2004 , p. 36 (Exhibit EC-130). WT/DS291/R/Add.7 
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                                                      44. Does the agronomic usage of the herbicides gl yphosate and glufosinate-ammonium differ?  
While glyphosate has multiple uses (pre-seeding burn-off, post-emergence, desiccation), glufosinate-
ammonium primarily is used as a selective herb icide on tolerant crops, with some exceptions.32  What 
impact do these different uses have on the potential for glufosinate-tolerant crops to become pests?  Could the "problem" of HT volunteers be addressed by  restricting the types of uses of the herbicide? 
45. The experts' opinion supports Canada's asserti on that risk management measures mitigate any 
"problems" associated wi th herbicide tolerance.33   However, on p. 15, Dr. Snow states that "by the 
time the spread of herbicide resistan ce is detected in free-living pest populations, it may be too late to 
prevent these plants from proliferating further."  She then cites a "problem" that has arisen in Canada 
in relation to the widely spread transgene conferri ng tolerance to glyphosate.  However, there is little 
evidence in the literature of herbic ide-resistance in weeds from the use of herbicides associated with 
GMHT crops.  To the best of Canada's knowle dge, there are few repor ted weeds resistant to 
glyphosate34 and no reported weeds resistant to glufosinate-ammonium.35  Indeed, resistance in weed 
populations to herbicides used in conjunction with  non-GMHT crops developed through mutagenesis 
(e.g. varieties tolerant to imidazolinone) is a far greater problem.36 
46. In terms of managing this "problem", the scien tific literature suggests that multiple herbicide-
resistant oilseed rape can be c ontrolled by alternative herbicides.37  Thus, the "problems" identified 
relate solely to the loss of efficacy of one type of  weed management option, namely the application of 
the herbicide to which the plant is tolerant.  This does not necessarily imply the weeds are harder to 
control.  Can the experts confirm that the sta ndard herbicide control measure for non-HT and HT 
oilseed rape (both biotech and mutation induced ) is the application of phenoxy herbicides? 
47. Canada would be grateful if the experts could clarify to what extent these "problems" are 
comparable to problems that may be encountered w ith the use of herbicides generally.  Would it be 
fair to conclude that one of the purposes of soun d agricultural management is to prolong the efficacy 
of the herbicide in question?  Is this an environmental issue or an agronomic issue?  
48. Dr. Squire indicates that more serious problems relating to the persistence of biotech HT 
crops will arise if labelling or marketing ‘rules' re quire non-biotech crops to meet high purity levels.38  
 
32 To Canada's knowledge, glufosinate-ammonium is used for weed control in orchards, vineyards, 
vegetable cultivation and as a desiccant for potatoes and oilseed rape. 
33 Canada Second Written Submission, para. 162. 
34 Glyphosate mode of action is Glycine.  GLYCINES (G/9) Resistant Weeds by species and country, 
Weed Science.org  "Glyphosate" 2003; available online 
http://www.weedscience.org/summary/ChemFamily Sum.asp?lstActive=162&btnSub1=Go&lstHRAC = (Exhibit 
CDA-185). 
35 Glufosinate-ammonium mode of action is Glutamine synthase inhibitors.  There are currently no 
reported cases of weed resistance to GA. 
36 Imidazolinone mode of action is ALS inhibitor.  ALS INHIBITORS (B/2) Resistant Weeds by 
species and country, Weed Science.org  "Imazamox" 2003; available online 
http://www.weedscience.org/summary/ChemFamily Sum.asp?lstActive=265&btnSub1=Go&lstHRAC = (Exhibit 
CDA-186). 
37 Beckie H, (2004), Multiple herbicide-resistant canola (Brassica napus) can be controlled by 
alternative herbicides .  (Exhibit CDA-127).  Also see, Senior, I.J ., et al, "Herbicide sensitivity of transgenic 
multiple herbicide-tolerant oilseed rape" Pest Management Science  58:405-412 (2002)  Pest Management 
Science 58, 405-412, Section 4 - Conclusion (Exhibit CD A-187) and Sweet, J., et al , "Botanical and rotational 
implications of genetically modified herbicide tolerance in winter oilseed rape and sugar beet (BRIGHT 
Project)" Home-Grown Cereals Authority (HGCA) , Project Report No. 353 (2004), Chapters 1, 2, 3, 7, and 8 
(Exhibit CDA-188). 
38 Answers to the Panel's Questions from Dr. Geoff Squire, 6 January 2005, p. 8. [hereinafter Squire]  WT/DS291/R/Add.7 
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                                                      In the light of the definition of "pest" in ISPM No. 11, Canada would be grateful if Dr. Squire could 
clarify whether labelling or coexistence requireme nts alone can affect whether a plant could be 
considered a "pest" under the ISPM No. 11.  In othe r words, could the mere presence of a transgene 
be considered to be "injurious to plants or plant products"?  Does Dr. Squire agree or disagree with Dr. Snow's statement that "gene flow do es not represent an environmental concern per se , unless it 
results in unwanted biological consequences"?
39 
49. In terms of post-market monitoring, Dr. Squire  indicates that the type of monitoring would 
differ depending on the purpose of the monitoring, whether for the presence or abundance of HT 
crops or for the impact of HT cropping on biodiver sity and ecosystem functioning.  Canada agrees 
that the monitoring provisions of ISPM No. 11 are applicable to monitoring for the establishment and 
spread of potential "pests" including HT plants.  However, as Dr. Squire acknowledges, the impacts 
on biodiversity or the ecosystem of HT cropping are not caused by the GM crop per se , but the weed 
management program, including the mode of action, dosage and timing of herbicides.  Could Dr. Squire clarify why he considers the ISPM No. 11 relevant to the monitoring of impacts on 
biodiversity and the ecosystem arising from the app lication of herbicides?  In Canada's view, the 
monitoring plans adopted in this regard should not differ from monitoring plans for assessing the 
impact of changes in agronomic pr actices on biodiversity generally. 
7. On the basis of the information before the Panel, is there any scientific evidence to support the hypothesis that repeated use of a given biotech herbicide tolerant crop has adverse 
effects on flora and fauna, including soil micro- and macro-fauna?  If so, how does this compare 
with any similar risks of adverse effects from the repeated use of a non-biotech herbicide 
tolerant crop (i.e, one developed through mutagenesis)?  
 
50. Drs. Squire and Andow respond to this question.  Dr. Squire discusses the Farm Scale 
Evaluation (FSE), noting that "the difference in weed management rather than the GM or conventional crop plants per se was the effective agent."  Whet her GMHT cropping resulted in a 
negative or positive impact on biodiversity depe nded on the "severity of the conventional 
management."  Dr. Squire concludes that "in principle, there should be no difference between the effects of GMHT cropping and non-biotech HT cropping".   Canada would be grateful if Dr. Squire 
could indicate whether he agrees that the conclusi ons of the BRIGHT project report, to which he 
refers, are valid.
40 
51. In terms of impacts on biodiversity, it is important to recognize that the very purpose of 
agriculture is to reduce biodiversity in the area under cultivation in order to favour one species over 
other species that compete for nutrients, moisture etc.  However, biodiversity can be preserved by 
adopting sound agronomic practices such as crop rotati on and leaving fields fallow.   Indeed, a far 
more dramatic impact on biodiversity in the UK ha s been the widespread adoption of autumn-sown 
crops (such as winter oilseed rape), which reduces the amount of time a field is left fallow.  The point 
here is that changes in agronomic practice affect biodiversity.   There is no principled reason to 
subject GMHT cropping to disproportionately great er scrutiny than other agronomic practices (in 
particular, non-GMHT cropping). 
52. Dr. Squire also concludes that "[a]ll eviden ce from small-scale work in field plots and 
containers points to the herbicides glyphosate or glufosinate-ammonium being much less directly toxic to soil fauna than other agrochemicals and the GMHT plants themselves having no effect on soil 
 
39 Snow, p. 5. 
40 Exhibit CDA-188. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
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 organism different from that of non-GM plants."41  In Canada's view this c onclusion is consistent with 
relevant scientific evidence.   
53. Dr. Andow provides a somewhat more qualified response stating that "if all the factors in 
paragraphs 07.09 through 07.13 ar e equivalent between the GMHT and non-GMHT crop, then there 
will be no predicted differences  in the risks of adverse effects from the repeated use of a GMHT or 
non-GMHT crops."42 
54. Nonetheless, Dr. Andow raises a number of e ither irrelevant or scientifically unsupported 
propositions to suggest that GMHT crops may cause "adverse effects", without regard for potential 
adverse effects caused by non-GMHT crops.  First, Dr. Andow implies that a GMHT and its related 
herbicide use are "so tightly correlated" that adver se effects of herbicide use should be attributed to 
the GMHT crop.  He fails to indicate whether th e same concern holds true for non-GMHT crops and 
associated herbicides.  Moreover, Dr. Andow fails to  point out that there are many variables that 
influence the effectiveness of an herbicide in cont rolling weeds (e.g. mode of action, dosage, timing 
and frequency of application). 
55. Second, Dr. Andow states that "[t]here is abundant evidence that repeated use of a given 
biotech herbicide tolerant crop would likely result in the evolution of resistance in weeds to the 
herbicide."  As Canada has indicated under Questi on 6, there is little evidence in the literature of 
herbicide-resistance in weeds from the use of herb icides associated with GMHT crops.  Indeed, the 
fastest growing problem for resistance in weed populati ons is for those tolerant to herbicides used in 
conjunction with non-GMHT crops de veloped through mutagenesis ( e.g. varieties tolerant to 
imidazolinone). 
56. Third, Andow questions the conclusions of the FS E and states that "I believe that it is likely 
that additional adverse effects on non-target  organism may be reported in the future."43  Dr. Andow 
does not provide support for this belief nor does he  evaluate whether the same proposition holds true 
for non-GMHT crops. 
57. Fourth, Dr. Andow asserts that "[g]ene flow from a GMHT crop to a weed relative can create 
weeds that are more difficult to control" and claims  that "[t]his occurred in GMHT oilseed rape in 
Canada."  However, he cites no evidence to support this assertion.  The clai m that weeds are more 
difficult to control is without foundation.44  The standard herbicide control measure for non-HT and 
HT oilseed rape (both GM and mutation induced) is the application of a phenoxy herbicide. 
58. Fifth, Dr. Andow raises the issue of so-calle d "contamination" of c onventional crops resulting 
from gene flow from a GMHT (the "co-existence" issue).  As Dr. Andow acknowledges in his 
response to Question 103, whatever "economic loss" that may result is not associated with damage to 
plant life or health.45  For instance, in response to Question 103, he argues that the definition of 
"adverse effects" is a relative concept and cites the example of the organic farmer who perceives 
"contamination" to be an adverse effect because "it removes his or her product from the organic food 
stream."  However, this has nothing to do with adverse effects on the environment.  Even the 
European Commission has acknowledged that "co-existence" concerns the "potential economic 
                                                      
41 Squire, p. 10. 
42 Andow, para. 7.14. 
43 Andow, para. 7.03. 
44 Beckie et al.  Multiple herbicide-resistant canola can be controlled by alternative herbicides , Exhibit 
CDA-127. 
45 Andow, para. 103.03  WT/DS291/R/Add.7 
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                                                      impact of the admixture of GM and non-GM crops."46  The economic impact of the admixture of GM 
and non-GM crops is not a relevant consideration under Directive 2001/18 , as this directive is 
concerned with the adverse effects on the environment.47  Importantly, this "potential economic 
impact" is a result, not of damage to plant life of health, but by the supposed inability of European 
farmers to satisfy either low tolerances for adve ntitious GM presence set fo r maintaining "organic" 
status or low thresholds for GM labelling requirement s.  For instance, in terms of organic agriculture, 
as no threshold has been set for adventitious presence of GM products, the general threshold of 0.9% 
applies.48  However, organic regulations in the EC  permit the use of seeds developed through 
mutagenesis, while GMO seeds are seen as antithetical to the philosophy of organic agriculture.    
59. In any event, Dr. Andow is not qualified to provide expert advice on the extent of "economic 
loss", if any, that may be sustained by the organi c or conventional farmer arising from the admixture 
of GM and non-GM products.  Indeed, the EC in this  proceeding, while referring to the "risk" of co-
existence, has notably failed to put forth any analys is of the extent of any potential economic harm in 
this regard. 
60. Sixth, although Dr. Andow acknowledges that "the re are no reports of adverse effects on soil-
micro- or macro-flora or fauna…"49, he advises the Panel "not [to] infer that the absence of 
information implies an absence of effect."  Nowhere does Dr. Andow di scuss whether the same 
proposition holds true for non-GMHT crops. 
61. Seventh, whatever the merits of Dr. Andow's theoretical argument that hemizygous traits are 
more dominant that heterozygous, Dr. Andow is simply incorrect when a sserting that "GMHT are 
typically hemizygous."50  It is common knowledge among experts that crops that are not hybrid crops 
(e.g. canola, cotton, soybean) are homozygous, not hemizygous.  For instance, GT73 oilseed rape is 
homozygous.  Conversely, hybrid crops may be a combination of hemizygous and homozygous.  In 
Ms8/Rf3, half the plants are hemizygous and half homozygous for the HT trait.  In any event, Dr. 
Andow's argument appears to be so qualified as to be speculative. 
62. Eighth, Dr. Andow argues in para. 7.10 that GMHT transgenes are expressing all the time, 
while non-GMHT transgenes may or may  not be, and therefore this may enable the herbicide to be 
used for a longer period of time resulting in a gr eater degree of weed reduction.  However, as Dr. 
Andow points out, the weed reduction is a function of herbicide use.  The simp le solution is to use 
less herbicide. 
63. As a general comment, nowhere does Dr. Andow refer to the fact that, in Europe at least, HT 
crops developed through mutagenesis are not subject to detailed risk  assessments, and so the potential 
concerns about unintended effects, adverse effect s on flora and fauna and "biogeochemical cycles", 
and adverse effects caused by the herbicides as sociated with these crops (imidazolinone and 
sulfonylurea) go practically ignored by European regulators.  Moreover, nowhere does Dr. Andow 
acknowledge the environmental be nefits of glyphosate and glufosinate-ammonium over other 
conventional herbicides.  In Canada's view, his r esponse to Question 9 is unbalanced and speculative. 
 
46 Commission Recommendation of July  2003 on guidelines for the development of  national strategies 
and best practices to ensure the coexistence of genetically modified crops and organic farming , p. 6 (Exhibit 
CDA-165). [emphasis in original] 
47 Ibid, p. 7. 
48 Ibid, p. 12. 
49 Andow, para. 7.06. 
50 Andow, para. 7.09. WT/DS291/R/Add.7 
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                                                      8. What are the different detection methods cu rrently available for testing for the presence 
of material from genetically modified plants?   
 
(a) Have commercially available detection methods changed since the mid- 1990's?  
Were methods available in the mid-90's event specific? 
(b) Please outline the steps necessary to va lidate a detection method, including the 
determination of what types of reference materials needed and differences in validation steps for qualitative and qu antitative detection methods.   
(c) What are the differences in the intended uses of qualitative and quantitative detection methods?  What are the di fferences between event specific and non-
event specific detection methods?  How does the availability of different types of detection methods relate to risk assessment and risk management processes? 
64. Only Dr. Nutti provided a response to Question 8.   Dr. Nutti indicates that protein-based and 
DNA-based detection methods became available in the beginning of the 1990s.  Both methods can be used in a qualitative and a quantitative fashion.  Qualitative methods indicate the presence or absence 
of an analytical target (analyte) while quantita tive methods measure the quantity of the analyte 
present.
 51  Dr. Nutti states that protein-based methods can confirm the presence or absence of specific 
proteins expressed by different transgenic events and, while not event-specific, can identify uniquely 
most commercial events. 
65. Dr. Nutti indicates that the type of detection method selected depends on the intended purpose 
of the detection.  She concludes "[d]etection methods as applied to food or feed labelling do not have a direct role in risk assessment or risk manage ment".  Protein-based detection methods may be 
relevant to assess dietary intake and exposure to  expressed proteins, but the "common understanding 
of detection methods is that they are used to descr ibe the presence or absence of GMO grain (seed) in 
the context of conventional grain (seed)."
52  Hence, DNA-based event-specific quantitative detection 
is not necessary to conduct a risk assessment. 
66. Dr. Healy, in answering Question 17, also c onfirms that quantitative detection "is not a 
necessary component of a safety assessment" although it is an integral part of enforcement capabilities 
especially for consumer labelling regulations.53  Thus, to the extent that the approval procedures 
under Directive 2001/18  and Regulation 258/97  were delayed on the basis of the need for a 
quantitative event-specific detection method, these delays are not justified. 
9. In what ways does molecular characteri zation inform the risk assessment for any 
particular biotech product?  Can a risk assessment be carried out in the absence of a comprehensive molecular characterizati on of each transformation event? 
 
67. All experts who responded agreed that mo lecular characterizati on was an important 
component of the risk assessment process.  All the experts, save Dr. Andow, refer to Codex 
Guidelines for the Conduct of Food Safety Assessm ent in Foods Derived from Recombinant DNA 
Plants .  In Canada's view, Dr. Healy's response most clearly articulates the importance of molecular 
characterization for a risk assessment.  As Dr. Healy states: 
 
51 Nutti, p. 9. 
52 Nutti, p. 10.  Also see Dr. Nutti's response to Question 17, p. 15. 
53 Healy, p. 12.  WT/DS291/R/Add.7 
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 The molecular characterisation is considered to be a very important part of the safety 
assessment of a biotech product.  It provides information about the number of copies of the transgene(s) that have been inser ted, presence of any multiple copies at the 
same or dispersed insertion site(s) and the structural organisation of the inserted transgene(s).  The molecular characterisation also includes an analysis of the stability 
of the inserted DNA.  Together this information provides verification that the intended genetic modification has occurred and provides some indication as to the 
likelihood of any unintended changes.  Howe ver, the molecular characterisation is not 
the only mechanism for identifying unintended effects and the information from such studies should be considered in conjunc tion with the information from the other 
elements of the safety assessment.
54
68. Dr. Healy also addresses the issue as to how comprehensive the molecular characterization 
should be in order to fulfill the requirements of an appropriate safety assessment.  In this regard, she 
emphasizes that the "answer to this question depends on the type and quality of information available 
for the three elements of the safety assessment, th e information revealed from these studies and the 
state of the scientific knowledge about the gene(s ) to be transferred, the donor organism and the 
recipient organism."55  She also recognizes that over time, technologies to analyse the molecular 
biological and biochemical characteristics of biotech products improve.  However, this does not mean that products that were approved before such tec hnologies were developed are any less safe.  Canada 
shares this view.  The tools that will be availa ble in future for assessing molecular biological and 
biochemical characteristics will likely make today's tools seem rudimentary.  However, the inevitability of future technological innovation should not paralyze decision-making today. 
ISSUE 1  
 
Questions:  
 
Bayer hybrid oilseed rape (MS8/RF3)  
C/BE/96/01  (EC chronology 63) 
 
14. Given the information before the Panel, including the conclusions of the EC SCP 
(EC-63/At.54) in relation to the potential persi stence or invasiveness of Bayer hybrid oilseed 
rape (MS8/RF3), would this product qualify as a po tential pest according to ISPM 11?  If so, are 
the proposed post-market monitoring plans consistent with the monitoring and review 
principles described in ISPM 11?    
 
69. Both Drs. Snow and Squire agree that Ms/Rf3 has the potential  to be a pest on the basis that 
oilseed rape generally leaves volunteer and feral descendents, which can be considered pests.56  
Similarly, both experts agree Ms8/Rf3 is no more likely to be a pest than conventional oilseed rape, except where the herbicide glufosinate-ammonium is  used.   Dr. Snow concludes if glufosinate-
ammonium became widely used resulting in an in crease in herbicide-resistant volunteers and weeds, 
"other methods of weed control" could be used to manage the problem. 
70. Dr. Andow appears to disagree, claiming that th ere is not sufficient information before the 
Panel to determine whether Ms8/Rf3 qualifies as a pest.  Specifically, he states that the SCP failed to consider whether Ms8/Rf3 had a higher release ra te or determine "wheth er contamination of 
                                                      
54 Healy, p. 2. 
55 Healy, pp. 2-3. 
56 Snow, p. 17, Squire, p. 12. WT/DS291/R/Add.7 
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                                                      conventional varieties was an injury to plants."57  In relation to the higher release rate, it is noteworthy 
that the SCP considered various factors affecting th e persistence of Ms8/Rf3 and concluded that "the 
dispersal of transgenic rape seed should not be significantly different from that of the untransformed 
plants" and "[m]odified rape is no more invasive than unmodified plants."58  In relation to the issue of 
"contamination of conventional varieties", it would be helpful if Dr. Andow could distinguish 
between injury to plant health or life and poten tial "economic loss" resulting from the "co-existence 
issue".59 
71. In terms of post-marketing monitoring, Drs. Andow, Snow and Squire conclude that the 
proposed monitoring plans are consistent with th e monitoring and review principles described in 
ISPM No. 11.  While Dr. Andow indicates that the proposed plan is "the most thorough and well-considered of any of the monitoring plans in the ma terial before the panel", both he and Dr. Squire 
suggest more information should be required.  It may be useful, however, for the experts to indicate precisely what they view the objectives of the monito ring plans to be and thus what specific additional 
information is lacking.   Moreover, in order to place the information requirements into context, it may 
be useful to compare what they consider to be appropriate monitoring require ments in this situation 
with monitoring requirements to detect the spread of resistance to herbicides more generally.   
15. Given the information before the Panel, including the conclusions of the EC SCP, was the information regarding the assessment of the long-term effect of the newly expressed protein 
on the biogeochemical cycle and the food chain requested by the Italian CA (EC-63/At.87) 
necessary to ensure that conclusions of the safety assessment were valid? 
 
72. Canada agrees with Dr. Nutti's analysis that the request by the Italian authorities cited in 
Question 15 was not necessary to ensure that the conclusions of the safety assessment of the newly 
expressed protein in the food chain.60  Canada also notes that Dr. Andow concludes that the request 
was "not clear or specific enough to be considered necessary."61 This underscores Canada's argument 
that certain EC Member States appear to have b een stalling the approval process for biotech products 
by submitting vague and unjustified requests for add itional information.  Canada agrees with Dr. 
Andow that requests for additional information in the context of an approval procedure should be 
"clear and specific".  A request for additional info rmation should be based on a rational assessment of 
the information included in an application.  If that information, or prevailing scientific knowledge, does not suggest any risk, additional requ ests for information are not warranted. 
16. Given the information before the Panel, in cluding the conclusions of the SCP, was the 
information regarding molecular characterization of this product requested by the lead CA 
(EC-63/At.107) necessary to ensure that conclusions of the safety assessment were valid?    
 
73. The two experts responding to this question reach similar conclusions.  Dr. Healy directly 
answers the question posed by the Panel: "The add itional molecular characterization data sought by 
the lead CA in 2002 were not required to demonstr ate the safety of food products derived from MS8, 
RF3, or MS8xRF3 hybrids…The totality of informati on provided in the dossier to that point in time 
contained sufficient information to support the validity of the conclusions of the safety assessment 
 
57 Andow, p. 27.  Also see, Andow's response to Question 13, pp. 25-26. 
58 Pending notification - Bayer hybrid oilseed rape (MS8/RF3) – C/BE/96/01  p. 6 (Exhibit EC-63 – 
attachment 54). 
59 See Canada's comments under Question 7. 
60 Nutti, p. 14. 
61 Andow, p. 29  WT/DS291/R/Add.7 
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                                                      without the need for the additiona l molecular characterization data  [requested by the Biosafety 
Council]."62 
74. Dr. Snape does not respond to the question po sed by the Panel concerning whether the 
additional information requested by the lead compet ent authority was necessary to ensure the validity 
of the conclusions of the safety assessment.  Dr. Sn ape's review of the information examined for line 
Ms8 has led him to conclude that no further info rmation is needed to approve these lines in the 
European Union.  However, in relation to Rf3, Dr. Snape suggests that more information on structural 
analysis of progeny plants is needed to ensure that  there is structural stability across generations.  In 
essence, he argues that the developer should have evaluated stability of integrated sequences in Rf3 using molecular analysis (genotypic data) in add ition to determining stability of inheritance using 
segregation studies (phenotypic data).  Canada would like to highlight that in the original submission evaluated by regulatory authorities,  the developer addressed stability of integrated sequences in Rf3 
using both molecular analysis (Southern blot) and se gregation data.  Moreover, in Exhibit EC-83/At. 
107, the Biosafety Council indicated that "[t]he documents are well documented and the experiments 
and the results are of a high standard."  Unlike Dr. Healy, who considered the totality of the 
information, Dr. Snape does not appear to have co nsidered that the two copies of the barstar gene 
contained in Rf3 are linked nor has he give n due consideration to the segregation data. 
17. Were detection methods commercially a vailable in 2001 sufficient to enable the 
detection of the transgenic proteins expressed by the plant line hybrid oilseed rape MS8/RF3?   
Given the information before the Panel, including the SNIF (EC-63/At.109) and the updated environmental risk assessment (EC-63/At.110-14 0), was additional information regarding a 
quantitative detection method (EC-63/At.141) necessa ry to ensure that conclusions of the safety 
assessment were valid?    
 
75. Dr. Healy's conclusions support Canada's position that the delay in the processing of Ms8/Rf3 
occasioned by EC requests for an "event-specific" quantitative detection method is not justified on the 
basis of safety considerations.  Dr. Healy concludes that quantitative immunoassay methods to detect the PAT protein were available as early as 2000.  She also clarifies that "event-specific quantitative" detection methods are not necessary in order to de termine the validity of a safety assessment, although 
such methods may be required for enforcement of  labelling regulations.  However, as Canada 
previously has argued, the wholesale suspension of an SPS procedure pending the adoption of labelling regulations unrelated to fo od safety is not a justifiable delay.
63  Accordingly, requiring the 
submission of a detection method, the sole purpose of  which is to facilitate enforcement of labelling 
regulations unrelated to food safety, is not a justif iable request in the context of a safety assessment. 
18. Given the information before the Panel, including the SNIF and the updated 
environmental risk assessment (referenced ab ove), was the information regarding molecular 
data requested by the CA (EC-63/At.144) necessar y to ensure that conclusions of the safety 
assessment were valid? 
 
76. Again, Dr. Healy responds to this question in a clear and concise fashion.  She concludes that 
the request for additional information was "simply" to update the dossier to conform to the new Belgian guidelines and that the additional informati on did not add substantially to the weight of 
evidence that supports the conclusions concerning the safety of Ms8/Rf3.  Thus, contrary to the EC's 
assertion, this information was not necessary in order to  conduct the risk assessment.  It is noteworthy 
as well that Dr. Healy found it "surprising" that this  additional information was only requested in July 
 
62 Healy, pp. 9-10. 
63 Canada Third Written Submission, para. 209. WT/DS291/R/Add.7 
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 2003,  over a year after the guidelines had been adopted, despite the fact that the development of the 
guidelines proceeded in parallel with the ongoing assessment of this application.  This supports Canada's argument that any resulting delay occasioned by this request should be attributed to the EC, 
not the notifier.
64 
19. Given the information before the Panel, including the SNIF, the updated environmental risk assessment and the clarification provided by the notifier (EC-63/At.147), was the information regarding ecological effects of this product on agricultural systems requested by the 
lead CA (EC-63/At.149) necessary to ensure that conclusions of the safety assessment were 
valid? 
 
77. The views expressed by Drs. Snow and Squire support the conclusion that the request by the 
Belgian authorities for more information about effects on "farmland diversity (macro-fauna, weed 
flora and microbial soil ecosystem), food web inte grity (trophic structure), population dynamics of 
key species, life-cycles etc." is not only vague, but impossible to answer without multi-year, large scale experiments.  It is reasonable to infer that given the impossibility of conducting such 
experiments prior to approval of the product, the effect , if not the intent, of this request was to thwart 
the application. 
78. Dr. Snow suggests that the concerns giving rise to  these questions are related to the use of the 
associated herbicide with HT crops, i.e.  that the use of glufosinate in conjunction with HT oilseed 
rape may be more effective at controlling weeds, which may have a deleterious effect on fauna and 
flora.  Dr. Squire underscores the need for a "sta ndard or comparator."  Canada agrees and submits 
that the "standard or comparator" should be othe r weed management strategies, both herbicide and 
non-herbicide based. 
79. Dr. Snow indicates that some of the data  sought by the Belgian authorities seems 
"unnecessary".65  It may be helpful if she could elaborate.  It also may be helpful for either expert to 
identify whether similar types of information is sought in determ ining whether to approve other 
herbicide-based weed management strategies generally , including the type of herbicide (e.g. modes of 
action66), appropriate uses (e.g. pre-seeding burn-off67, pre-emergent and post- emergent in-crop weed 
control) and desiccation68. 
80. Dr. Andow responds by indicating that some of  the additional information requested by the 
Belgian CA may be necessary and so me not necessary.  In paragraph 19.04 of his report, Dr. Andow 
states that the notifier's response is "insufficient"  and therefore a request for additional information 
necessary.  However, point 4 refers to "direct and indirect interactions between the GMHP and target 
organisms …(if applicable)."  Point 4 appears to be rele vant only to those crops specifically developed 
for pesticidal qualities; consequently it is inapp licable in the context of this application.  
                                                      
64 Canada's Third Written Submission, para. 231. 
65 Snow, p. 18. 
66 There are several types of modes of action for he rbicides, including amino acid synthesis inhibitiors, 
growth regulators, growing point disintegrators, seedling growth inhibitors, photosynthetic inhibitors cell 
membrane disruptors, and pigment inhibitors. 
67 "Pre-seeding burn-off" refers to the application of  herbicides to destroy established vegetation prior 
to seeding. 
68 "Desiccation" refers to the application of a substa nce (desiccant) to a crop to accelerate the drying of 
plant tissue in order to aid in the harvest operation.  De siccants are typically applie d to increase the uniformity 
of the moisture content in seeds.  WT/DS291/R/Add.7 
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 81. In relation to the Belgian CA's request for a dditional information concerning "biogeochemical 
cycles", Dr. Andow appears to misstate the notifier's claim.  The notifier did not claim that oilseed 
rape "does not participate in any biogeochemical cy cles", but only that "oilseed rape has not been 
identified as serving a key function  in such cycles."69   Moreover, Dr. Andow's response appears to be 
inconsistent with his earlier conclusions in para. 10.13.70  In March 2000, the Italian CA had 
requested additional information on the impact  of glufosinate-tolerant oilseed rape on 
"biogeochemical cycles".71  In dismissing that request as unclear, unspecific and scientifically 
unjustified, Dr. Andow concludes that: 
…[t]he request by the Italian CA [for info rmation on biogeochemical cycles] is not 
clear or specific enough to be considered necessary.  There are hundreds of possible 
processes in biogeochemical cycles that could be investigated…Unless the Italian CA can point to prior regulatory precedents wh ere these terms are clarified, the phrasing 
of the request is not scientifically justified. 
82. However, when the same request for additiona l information on the possible immediate and/or 
delayed effects on biogeochemical cycles was made by the Belgian CA nearly three years later in October 2003, Dr. Andow appears to conclude that the request for additional information was necessary.  No explanation is provided for the a pparent inconsistency in  Dr. Andow's views.  
Moreover, while Dr. Andow concludes that 269 days seems "excessively long to complete the review and articulate questions", he does not comment on the fact that the first request for information on 
"biogeochemical cycles" was made in March 2000 by Italy, to which the notifier responded in 
November 2000.
72  It should be noted that neither the Italian nor Belgian CA, or any other EC 
Member State for that matter, raised concerns about the perceived inadequacy of the notifier's reply.  
There is no reason why Dr. Andow's conclusion with  respect to Roundup Ready fodder beet – that a 
failure to follow-up on a reply indi cates that the response was satisfactory73 – should not apply here. 
83. Dr. Andow cites the fact that root and leaf litter participate in carbon cycles and that this 
"may" have subtle effects on phosphorous cycles.  However, Dr. Andow does not cite any scientific 
research to support this supposition nor does he point to any information in the dossier that would 
provide a compelling reason to suspect that the pre sence of the transgene would materially affect 
phosphorous cycles.  The notifier first addressed this issue in its response to the Italian CA's initial 
request in March 200074 and then reiterated its response in its December 2002 updated Environmental 
Risk Assessment, stating that "there are no reasons to expect that the newly inserted traits alter the 
cycling of elements or organic nutrients…".75  The rationale for this conclusion was in part that "the 
PAT enzyme that is produced in the glufosinate-tolerant oilseed rape is highly specific for its only 
known substrate, phosphinotricin" and extensive st udies on the comparison of bacterial rhizosphere 
populations of transgenic and non-transgenic oilseed rape.  
84. Dr. Andow's response to this question raises a general issue of the sufficiency of information 
required to conduct a risk assessment.  It is quite possible to continue to pose questions regarding 
virtually any possible ecological interaction, leadin g to an endless series of studies, of no or limited 
                                                      
69 Exhibit EC-63- attachment 112, p. 40. 
70 Andow, p. 29, para. 19.10. 
71 The Italian CA requested this information for both oilseed rape Falcon GS40/90 and Ms8/Rf3.  Dr. 
Andow's response is the same for both products. 
72 Exhibit EC-63 – attachment 88. 
73 Andow, para. 22.05. 
74 Exhibit EC-63 – attachment 88.   
75 Exhibit EC-63 – attachment 112, p. 40. WT/DS291/R/Add.7 
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                                                      value in assessing the risks of a particular product.  As Dr. Snow indicates, it is not always clear how 
to distinguish between what regulators "need  to know" and what is "nice to know".76  It might be 
helpful if Dr. Andow could explain why of all th e "hundreds of possible processes in biogeochemical 
cycles that could be investigated",77 he singled out the impact of phosphorous cycles as justifying a 
request for additional information.  It might also be useful if Dr. Andow could identify criteria that in his view would be suitable for determining when  additional information was necessary to conduct a 
risk assessment.  Lastly, Canada would appreciate Dr. Andow's views on whether the degree of information necessary to conduct a ri sk assessment should be consistent  across comparable situations 
and whether the fact that the EC does not even require a superficial environmental risk assessment for herbicide-tolerant crops develope d through mutagenesis informs the level of information that should 
be sought in assessing risk. 
85. In terms of Point 9, Dr. Andow concludes that, in part, the failure by the notifier to address 
changes in tillage practices justifies the request for a dditional information.  This is a surprising remark 
given that one of the benefits of herbicide-tolerant  crops is that it enables farmers to adopt low-tillage 
or no tillage farming practices, practices that are wide-acknowledged to be en vironmentally beneficial 
by reducing soil erosion, moisture loss and siltation.78  It is curious that Dr. Andow would consider 
the failure to identify a widely-recognized enviro nmental benefit as justification for delaying the 
processing of an application. 
86. Lastly, Dr. Andow states that the notifier faile d to address whether the "associated herbicide 
use would have adverse environmental effects."79  To the contrary, the notifier indicated that 
registration for the specific use of glufosinate-ammonium with the crop in question would be addressed under the applicable le gislation in accordance with EC Directive 91/414/EEC .  Building on 
his comments in para. 6.15, Dr. Andow appears to assume that the specific use of herbicides in conjunction with GMHT crops should be considered under Directive 2001/18  and not under Directive 
91/414/EEC , the legislation specifically established to regulate plant protection products and their 
uses.
80  The impact of the use of herbicides is not relevant to a safety assessment of the crop in 
question. 
20. Are the conclusions and recommendations in the Report of the Group of Experts Mandated by the Belgian Biosafety Advisory Council (EC-63/At.167 pp.20-21) regarding the agricultural guidelines proposed by the applicant consistent with the Belgian Biosafety Advisory 
Council's conclusion that the agricultural guidelines are "impracticable, hardly workable and hard to control"?  
 
87. Both Drs. Andow and Squire responded to this question.  Unfortunately, there appears to be 
some confusion as to the meaning of the Panel's qu estion and as what the Belgian Biosafety Advisory 
Council was referring to when it stated that "a  number of recommendations of the agricultural 
guidelines are impracticable, hardly workable and hard to control in current agricultural practices."  It 
is clear that the Group of Experts considered the agricultural guidelines proposed by the notifier and made recommendations to apparently strengthen the guidelines.  What is not clear is what the BBAC 
is referring to in reaching its conclusion.  Dr. Squi re lists several issues that he considers to present 
practical problems in implementing the guidelines.
81  However, these issues refer to recommendations 
 
76 Snow, p. 6. 
77 Andow, p. 23, para. 10.13. 
78 Snow, p. 9. 
79 Andow, para. 19.12. 
80 Canada Third Written Submission, paras. 77 and 245. 
81 Squire, p. 13.  WT/DS291/R/Add.7 
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 made by the Group of Experts not the agricultural guidelines proposed by the notifier.  Dr. Squire 
does not identify specific problems with what the no tifier proposed.  Dr. Andow attempts to divine 
whether the Group of Experts considered the guidelines proposed by the notifier to be "impracticable, 
hardly workable and difficult to control", desp ite the fact that they made no such finding. 
88. The Panel's question appears to be whether th e conclusion of the BBAC that the agricultural 
guidelines proposed by the notifier are "impracticable, hardly workable and hard to control" is 
consistent with the conclusions a nd recommendations of the Group of Expe rts.  Given the fact that the 
Group of Experts did not express such a conclusion and in fact made recommendations to augment 
the proposed agricultural guidelines, it is difficult to conclude that the BBAC based its conclusion on the Report of the Group of Experts.  To the contrary, the BBAC appears to have reached its own conclusion without providing any analysis. 
89. In any event, what appears to be lost in this discussion is an evaluation of whether any risks 
associated with the cultivation of Ms8/Rf3 can be managed by the adoption of the proposed 
agriculture guidelines.  Drs. Snow and Squire indica te that risk management options are available to 
address any issues that may arise, although they indi cate that this will depend on local conditions and 
agronomic practices.82  What is missing from the BBAC analysis is what elements of the proposed 
agricultural guidelines and recommendations are "impr acticable, unworkable and difficult to control".  
These elements do not relate to risk management, but to the "co-existence" issue. 
Monsanto Roundup Ready oilseed rape (GT73)  
C/NL/98/11   (EC chronology 70) 
 
26. Given the information before the Panel, including the notification (EC-70/At.1-3), was 
the information regarding  molecular characteriza tion of this product requested by the Dutch 
CA and by the UK (EC-70/At.4, 7, and 8) necessary  to ensure that conclusions of the safety 
assessment were valid?   
 
90. No expert has responded to this question.  In any event, Canada does not contest that these 
early requests for additional information were scientif ically justified and thus, pursuing this issue does 
not appear necessary.83  The more important issue is whether the objections raised by EC Member 
States after the notification was circulated at the co mmunity-level were scientifically justified in the 
light of the favourable advice of the Netherla nds scientific body (COGEM) in January 2001 and 
Netherlands Competent Authority's favourable assessment.84  Canada submits that these objections 
were not justified, a conclusion c onsistent with the findings of th e EFSA GMO Panel that "sufficient 
molecular characterization has been carried out."85 
                                                      
82 Snow, p. 14.  Squire, p. 9. 
83 Canada's Suggestions Regarding Questions to be submitted to Experts, 16 August 2004, para. 11. 
Following the Netherlands' request for additional inform ation regarding molecular ch aracterization (attachments 
4, 7 and 8), the notifier submitted supplementary molecular analysis (attachment 10). 
84 Those objections and the notifier's response are summarized in Exhibit EC-70 – attachment 103, 
pp. 4-5. 
85 EC, EFSA, Scientific Panel on Genetically Modified Organisms, Opinion on a request from the 
Commission related to the Notification (Reference C/NL/98/11) for the placing on the market of herbicide-
tolerant oilseed rape GT73, for import and processing, under Part C of Directive 2001/18/EC from Monsanto (Question No. EFSA-Q-2003-078) , adopted 11 February 2004, online: 
http://www.efsa.eu.int/science/gmo/gmo_opinions/catindex_en.html , p. 14 (Exhibit CDA-35-N). WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
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                                                      27. Given the information before the Panel, including the notification, was the information 
regarding feed safety aspects of this product requested by the Netherlands (EC-70/At.8 and 13) 
necessary to ensure that conclusions of the safety assessment were valid?   
 
91. Only Dr. Nutti responded to this question.  For the sake of clarity, it may be helpful if Dr. 
Nutti could specify the information provided by the applicant to which she refers, given that she 
appears to have mistakenly cited exhibits that contain the request by the Netherlands – RIKILT-DLO, 
(attachments 8 and 13), not the information originally provided by the notifier (attachments 1 to 3).  In 
addition, Canada requests that Dr. Nutti identify th e "analysis done by the EC SCP" to which she 
refers.  To Canada's knowledge, the SCP did not analyze this application.  The only analysis 
undertaken by a Community-wide scientific commit tee was by the EFSA GMO Panel in February 
2004, well after the Netherlands – RIKILT-DLO's initia l request for additional information regarding 
feed safety. 
28. Given the information before the Panel, in cluding the notification and the SNIF (EC-
70/At.49-53), was the additional information provided in Monsanto's submission to the 
Commission (EC-70/At.84-97) necessary to ensure that conclusions of the safety assessment 
were valid?     
 
92. Drs. Andow and Nutti responded to this question.   The question is intended to determine 
whether the information that was considered by the Netherlands Competent Authority (including the 
updated notification) was sufficient to support the au thority's favourable risk assessment.  Put another 
way, were the objections raised by EC Member  States after the favourable assessment by the 
Netherlands Competent Authority unjustified.  If such  objections were justified, then presumably, the 
information supplied by the notifier in response to  those objections (Exhibit EC-70 – attachments 84-
97) was necessary to ensure that the conc lusions of the safety assessment were valid. 
93. Canada has no comments in relation to Dr. Nu tti's evidence, which s upports Canada's position 
that the objections by the EC Member States were  not necessary to ensure the validity of the risk 
assessment. 
94. Canada has the following comments on Dr. Andow's answer, which focuses only on 
monitoring.  By way of background, the notifier proposed a monitoring plan to identify the occurrence 
of adverse effects not anticipated in the environmental risk assessment.86  In its favourable assessment 
report, the Netherlands Competent Authority stated that, since the notification for GT73 oilseed rape 
only covers import and processing and does not incl ude cultivation, post-market monitoring of the 
product and its effects on the environment is not an is sue.  Nevertheless, given that a monitoring plan 
is required under Directive 2001/18 , the competent authority recommended that the company provide 
data of sales on an annual basis and amounts imported at key ports for each Member State, apparently 
in addition to what the notifier had already proposed.87  EC Member States objected to the adequacy 
of the monitoring plan insisting on more oner ous conditions. The notifier responded to these 
objections88 and submitted an updated monitoring plan.89  The EFSA, taking all of the information 
into consideration, concluded that the proposed m onitoring plan was acceptable in the light of the 
intended use of GT73. 
 
86 Pending notification - Monsanto Roundup Ready oilseed rape (GT73) – C/NL/98/11 (Exhibit EC-70 
– attachment 51). 
87 Exhibit EC-70 – attachment 66. 
88 Exhibit EC-70 – attachment 85, p. 22. 
89 Exhibit EC-70 – attachment 92, being Appendix 9 to Monsanto's response to reactions of EC 
Member States (attachment 85)  WT/DS291/R/Add.7 
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 95. Question 28 does not seek to determine whethe r the monitoring plan accepted by EFSA is 
adequate or meets the requirements of Directive 2001/18 .  The issue is the adequacy of the initial 
monitoring plan proposed by the notifier in the SN IF and whether the objections by the EC Member 
States to that initial plan were justified.  It is  important to emphasize that the underlying issue in 
respect of the monitoring plan is not whether the monitoring plan complies with Directive 2001/18  or 
how to interpret the provisions of that Directive (whether something is case-specific or not), but 
whether the proposed SPS measure ( i.e. the monitoring plan) is "based on" the risk assessment. 
96. Dr. Andow appears to assume that the adequacy of  the monitoring plan is to be determined by 
reference to the aims proposed by the EC Member States.  Canada disagrees.  The monitoring plan is 
to identify the occurrence of adverse effects on human health or the environment not anticipated in the 
environmental risk assessment.  The conclusions of the risk assessment are not based simply on "exposure", i.e. the likelihood of spillage, but the conseque nces for the environment in the event of 
unanticipated spillage, i.e. "adverse effect" or harm.   Given the conclusions of the risk assessment 
summarized succinctly by the UK competent authority - "the risk assessment does not identify risks in 
relation to human health or the environment from the use of GT73 oilseed rape as defined in the notification (i.e. for import and processing)" – there is no justification for imposing a monitoring plan to monitor so-called "contamination of other agricultural systems".
90 
97. Dr. Andow appears to accept as justifiable Italy' s concern with possible effects of glyphosate 
and its metabolites.91  Dr. Andow does not elaborate on this concern, which Canada understands as a 
concern that the residues of glyphosate sprayed on the oilseed rape may remain on the seeds and may 
cause adverse effects to the environment should the seeds be accidentally spilled.  Given that 
glyphosate metabolizes rapidly in the soil and is widely  used in the EC (indeed it is approved in most 
EC Member States), glyphosate residue cannot be a serious concern. 
98. Lastly, given that most of the processing faciliti es for oilseed rape are located in port areas, 
away from areas under cultivation, the probability of th e establishment and spread of oilseed rape into 
the environment is very remote. 
ISSUE 2  
 
Oilseed rape MS1 x RF1 (notification C/UK/94/M1/1)  
 
Safeguard measure of France 
 
59. Given the information before the Panel, in cluding the evaluations undertaken by the UK 
(EC-161/At.1), the Scientific Committee on Plants in May 1998 and May 1999 (CDA-35-A and 
CDA-69, respectively), and the European Commissi on in its Decision of February 1996 (CDA-
62), as well as the information submitted by Fr ance with respect to its safeguard measure (EC -
161/At. 3 to 11; CDA-68, CDA-70, CDA-71), is there an y reason to believe that the scientific 
evidence available to France in November 1998 and July 2001 was NOT sufficient to permit it to undertake an appropriate assessment of potential risks to human, plant and animal health, and the environment from the growing for seed production of oilseed rape MS1 x RF1?  If so, what scientific evidence do you believe was insufficient?   
 
                                                      
90 Commission Recommendation on Co-existence, p. 6 and 7.  "It is important to make a clear 
distinction between the economic aspects of co-existen ce and the environmental and health aspect dealt with 
under Directive 2001/18/EC on the deliberate release of GMOs into the environment." (Exhibit EC-165). 
91 Andow, para. 28.04, 28.22 and 28.26. WT/DS291/R/Add.7 
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 (a) If the evidence was not sufficient in November 1998 and/or in July 2001, was 
there sufficient evidence available to France in August 2003  to permit it to 
undertake a more objective assessment of potential risks to human, plant and 
animal health, and the environment from the growing for seed production of oilseed rape MS1 x RF1?  If not, what scientific evidence do you believe was insufficient?   
99. In his reply to this question, Dr. Squire says that France was concerned about the up-scaling 
issue (the uncertainty of what might occur if GMHT  crops were grown widely in the country) and that 
there was in fact insufficient inform ation available at that time to be able to predict accurately, for a 
country such as France, what the rates of spread and cross-pollination would be (GM to non-GM) if a 
large part of the rapeseed areas were GM.92  Dr. Squire states that even by the end of 2003 there was 
uncertainty as to what the field-to-field cross-pollination might be.93 
100. In her reply, Dr. Snow expresses the view that the SCP's assumption that the risk of 
establishment was low is not supported by the ev idence, including evidence that became available 
during 1998-2003.94  She concludes that France had valid reasons in 1998 to follow the advice of the 
CGB to carry out more research.95  According to Dr. Snow, France needed more information about 
the rate at which the transgene for glufosinate tole rance would spread to volunteer plants and related 
weeds.  By 2003, more scientific knowledge was available but ne w information was still coming to 
light about the spread and persisten ce of genes for herbicide tolerance.96 
101. Dr. Andow takes the position that the scientific evidence in 1998 on dispersal of oilseed rape 
pollen was not sufficient to complete an accurate  assessment of dispersal probability, but that 
"sufficient data appeared by the end of 2002".97 
102. Both Dr. Squire and Dr. Andow re ference an article published in Science .98  However, there 
were methodological problems with that study.  Specifically, the authors did not determine 
background levels of the ALS2 mutation prior to th e experiment; considering the extremely low levels 
obtained, what is ascribed by the authors to long distance pollen flow could just as easily be ascribed 
to population background levels of the mutation. 
103. Dr. Andow also speculates about the possibility th at fields of HT oilseed rape might not be 
harvested, with the result that that entire crop goes to seed – asserting this may require "exceptional" 
agricultural practices to control volunteers/weeds.  He states that "such possibilities were not 
considered by the SCP, and France may be concerned about such scenarios."99 However, apart from 
being purely speculative both as to the occurrence of the scenario a nd France's concerns, the putative 
problem he describes is not a problem specific to tr ansgenic oilseed rape.  In any event, control 
measures would be similar as between transgenic  and non-transgenic varieties, and effective 
mitigation measures exist, and tillage can always be employed as a last resort. 
104. Dr. Andow indicates that "in 2001 the French Biomolecular Engineering Committee (BEC) 
called for additional research in this area, but by  the middle of 2003, the BEC believed that it had 
                                                      
92 Squire, p. 15. 
93 Ibid. 
94 Snow, p. 19. 
95 Ibid., p. 21. 
96 Ibid. 
97 Andow, p. 81. 
98 Squire, p. 15; Andow, fn. 25. 
99 Ibid.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-59 
 
 
                                                      sufficient information to complete an assessment".100  This view seems to be borne out by the BEC's 
February 2004 opinion.101 
105. In contrast with Drs. Snow and Squire, and consistent with Dr. Andow's views, Canada 
considers that ample scientific evidence existed by the end of 2003 for France to complete a risk 
assessment.  The BEC seems to share that view given the opinion that it issued in February 2004.  In 
short, there is ample evidence on pollen flow, volunt eer persistence and management strategies at this 
time for France to have made a decision.  Interna tional seed certifying bodies have devoted extensive 
time and effort to examine issues of seed purity, hence proper management practices are well 
described. 
106. Dr. Andow also posits what France could have argued – but did no t – in 1998 in support of its 
prohibition on the marketing of oilseed rape Ms1/Rf1: that there was insufficient data to identify all of 
the possible environmental hazards of GMHT oilsee d rape; that the molecular characterization was 
insufficient; that the risk of evolution of  resistance in weeds not related to the Brassicae  had been 
incompletely assessed and management of these risks required additional scientific data; and that the 
data on non-target effects was insufficient.102  Given that he also notes that sufficient information was 
available by October 2003 to assess these risks, even assuming that he is correct – a matter that is not 
clear given the absence of any supporting references  or other documentation – it is not clear what 
value this information has in th e context of this proceeding. 
60. With reference to the definition of a risk assessment in the SPS Agreement (see 
Background above), to what extent does the scientific evidence and other documentation 
submitted by France evaluate the relevant risks to human, plant or animal health, and the 
environment from the growing of oilseed rape MS1 x RF1 for seed production?   
 
(a) How does the scientific evidence and oth er documentation submitted by France 
compare with the relevant internationa l guidelines for risk assessment and 
analysis identified above? 
107. Dr. Andow expresses the view that scientific evidence and other information submitted by 
France probably did not meet requirements fo r a risk assessment as defined in the SPS Agreement  or 
ISPM No. 11.103  He asserts, however, that the science, documentation and reasoning of France is 
consistent with Annex III of BSP.  Be that as it may, Annex III of the BSP is not an international 
standard or guideline as that term is defined in the SPS Agreement . 
108. Dr. Squire indicates that "it could be argued" that France's position was compatible with the 
"tone" of the definition of a risk assessment in the SPS Agreement , and compatible also with ISPM 
No. 11.104  Aside from the uncertain meaning of "it coul d be argued" and "tone", Dr. Squire does not 
really explain in what way exactly his view is supported by the facts. 
61. Does the scientific evidence and other in formation submitted by France support the 
adoption of a temporary prohibition on the growing of oilseed rape MS1 x RF1 for seed 
 
100 Ibid. 
101 French Commission du génie biomoléculaire (CGB) released a scientific opinion addressing the 
potential impacts on the environment arising from the cultivation of genetically modified oilseed/rape, 13 
February 2004 (Exhibit CDA-169). 
102 Andow, p. 81. 
103 Andow, p. 82. 
104 Squire, p. 15. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-60 
  
 production?  In light of any potential risks iden tified by France, what other risk management 
options were available in November 1998 and/or July 2001?  What other risk management 
options are now available? 
 
109. Dr. Snow considers that she does not have  enough information to answer the question.105  She 
indicates that seed production on a small scale probably would not justify a temporary prohibition; however, if the plants are grown on a fairly large scale (1000+ hectares/yr) she appears to be of the view that a temporary prohibition was justified.
106  According to her, the basic concern is that 
herbicide resistance genes would spread in conjunction with wider use of the herbicide over time and other herbicide resistance genes might be approved in  the future (e.g. glyphosate resistance) thereby 
compounding the problem.
107  She does not respond to the question about the availability of risk 
management options. 
110. In contrast, Dr. Squire says that risk manageme nt options exist to reduce the risk of spread 
and cross-pollination, but it cannot be eliminated.108 
111. In his answer, Dr. Andow expresses the view th at the adoption of a temporary prohibition can 
be justified on the basis of the scientific ev idence and other information submitted by France.109  
However, he seems to suggest that less restrictive risk management options were available to France in 1998 and 2001, such as phased-in cultivation, which would have allowed for a determination of scale effects.
110  He also appears to agree with Canada's position that the maintenance of the French 
prohibition is not justified when he says that "today several alternative risk management options are available…it would appear that France is now convinced that if HT volunteers or wild species occur that they can be detected rapidly enough and eliminated."
111  This view also appears to be borne out 
by the BEC opinion of February 2004.112 
Topas 19/2 (notification C/UK/95/M5/1)  
 
62. Given that oilseed rape Topas 19/2 was only approved for import of seeds for 
processing, what is the relevance of the findings of the UK farm scale evaluation study (EC-38) in terms of the assessment of potential risks from Topas 19/2? 
 
112. The experts all agree that the UK farm scale evaluation study (FSE) is not relevant to 
assessing the potential risks arising from the import and processing of Topas 19/2.113 
113. Their conclusions strongly support the argument that there is no scientific evidence regarding 
environmental risks to support either France's or  Greece's prohibition on the marketing of this 
product.  In fact, France's own scientists agree that  the environmental risks associated with importing 
and processing Topas 19/2 are no different from those associated with importing and processing 
conventional oilseed rape.114 
                                                      
105 Snow, p. 23. 
106 Ibid. 
107 Ibid. p. 24. 
108 Squire, p. 15. 
109 Andow, p. 83. 
110 Ibid. 
111 Ibid. 
112 Exhibit CDA-169. 
113 Squire, p. 15; Andow, p. 84; Snow, p. 24. 
114 Exhibit CDA-169, pp. 10-11 (translation).  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-61 
 
 
 Safeguard measure of France 
 
63. Given the information before the Panel, in cluding the evaluations undertaken by the UK 
(EC-162/At.1 to 3), and the Scientific Commi ttee on Plants in February 1998 (CDA-63), May 
1999 (CDA-65 and CDA-73), and the European Commission in its Decision of April 1998 (CDA-
61), as well as the information submitted by Fr ance with respect to its safeguard measure (EC-
162/At. 5, EC-161/At. 3 to 11, CDA-64, CDA-66, CDA-67), is there any reason to believe that the scientific evidence available to France in November 1998 and July 2001 was NOT sufficient to 
permit it to undertake an appropriate assessment of potential risks to human, plant and animal 
health, and the environment from the import and processing of oilseed rape Topas 19/2?  If so, 
what scientific evidence do you believe was insufficient? 
 
(a) If the evidence was not sufficient in November 1998 and/or in July 2001, was 
there sufficient evidence available to France in August 2003  to permit it to 
undertake a more objective assessment of potential risks to human, plant and 
animal health, and the environment from the import and processing  of oilseed 
rape Topas 19/2?  If not, what sci entific evidence do you believe was 
insufficient?   
114. The experts appear to share the view that sufficient scientific evidence was available to 
France to undertake an appropriate assessment of the potential risks associated with the import and processing of Topas 19/2, although they differ on when that evidence was available. 
115. Dr. Snow indicates that she found no convincing arguments for why further scientific 
research would be needed to investigate environmen tal effects of a product that is only intended for 
import and processing and not for cultivation.115  She states that "any seed  spillage that might occur 
when the seeds are delivered could be managed and that it is extremely unlikely that the seeds would be cultivated inadvertently."
116  
116. Dr. Andow states his view that "the rationale put forward by France does not argue that a risk 
exists that requires management."117  However, Dr. Andow goes on to list putative arguments that 
France could have made.  This is the same list as for Ms1/Rf1, including insufficiency in the 
molecular characterization and possible contamination of conventional oilseed rape varieties.  On the 
basis of that list, Dr. Andow asserts that, "given the information before the Panel, France could have 
argued in November 1998 that there was insufficient evidence to complete  a risk assessment.  
However, I believe that had France collected the necessary data to complete this risk assessment 
promptly after implementing their temporary prohibiti on that they could have had sufficient data to 
make a decision in 2001".118 
117. Apart from the questionable assertions regarding molecular characterization and the 
contamination issue, for which Dr. Andow does no t advance any evidence, and with which Canada 
does not agree, Dr. Snow and Dr. Andow express view s that support Canada's position that the French 
prohibition on the import and processing of Topas 19/2 is not justifiable on scientific grounds. 
64. With reference to the definition of a risk assessment in the SPS Agreement (see Background above), to what extent does the scientific evidence and other documentation 
                                                      
115 Snow, p. 25. 
116 Ibid. 
117 Andow, p. 84. 
118 Ibid., p. 85. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-62 
  
                                                      submitted by France evaluate the relevant risks to human, plant or animal health, and the 
environment from the import and processi ng of oilseed rape Topas 19/2?   
 
(a) How does the scientific evidence and oth er documentation submitted by France 
compare with the relevant internationa l guidelines for risk assessment and 
analysis identified above? 
118. Although Dr. Snow does not appear to answer th e question directly, her answer, which states 
that no further scientific research was needed,119 implies that France's scientific evidence and other 
documentation was irrelevant. 
119. Dr. Andow expresses the view that France scie ntific evidence and other documentation did 
not meet requirements of a risk assessment as defined in the SPS Agreement  or the requirements of 
ISPM No.11.120  Dr.Andow does express the view that the "science, documentation and reasoning of 
France are consistent with Annex III of the Cartag ena Protocol on Biosafety to the Convention on 
Biological Diversity."121  Dr. Andow refers specifically to section 8(f) of Annex III, which is 
concerned with situations "where there is uncertain ty regarding the level of risk".  Canada, however, 
is of the view that Annex III of the Cartagena Pr otocol does not constitute an "international standard" 
as that term is defined in the SPS Agreement .  In any event, the scientific evidence does not disclose 
that "uncertainty regarding the level of risk" existed.   Hence, Section 8(f) would not be relevant in this 
particular context. 
65. Does the scientific evidence and other in formation submitted by France support the 
adoption of a temporary prohibition on the import  and processing of oilseed rape Topas 19/2?  
In light of any potential risks identified by France, what other risk management options were available in November 1998 and/or July 2001?  What other risk management options are now available? 
 
120. The experts support the argument that there is no scientific justification for maintaining the 
French ban on Topas 19/2.  This contention is  also supported by France's own scientists.122 
121. In particular, Dr. Andow states that the scien tific evidence and other information submitted by 
France do not support the adoption of a temporary prohibition.123  He also asserts that other scientific 
evidence and information before the Panel could have  been used to support a temporary prohibition.  
However, it is unclear what other "scientific ev idence and other information" he has in mind in 
making this assertion.  In any event, he concedes that, even on these grounds, a prohibition would probably not be justifiable past 2001. 
122. In contrast to Dr. Andow's equivocation, Dr. Snow states clearly that she "did not find any 
convincing arguments for why further scientific  research would be needed to investigate 
environmental effects of a product that is onl y intended for import and processing and not for 
cultivation."124 
 
119 Snow, p. 26. 
120 Andow, p. 85. 
121 Andow, pp. 85-86. 
122 Exhibit CDA-169, pp. 10-11 (translation). 
123 Andow, p. 86. 
124 Snow, p. 26.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-63 
 
 
 Safeguard measure of Greece 
 
66. Given the information before the Panel, in cluding the evaluations undertaken by the UK 
(EC-162/At.1 to 3), and the Scientific Commi ttee on Plants in February 1998 (CDA-63), May 
1999 (CDA-65 and CDA-73), and the European Commission in its Decision of April 1998 (CDA-
61), as well as the information submitted by G reece with respect to its safeguard measure (EC-
162/At. 4, CDA-72), is there any reason to believe that the scientific evidence available to Greece in September 1998 was NOT sufficient to permit it to undertake an appropriate assessment of 
potential risks to human, plant and animal health, and the environment from the import and 
processing of oilseed rape Topas 19/2?  If so , what scientific evidence do you believe was 
insufficient?   
 
(a) If the evidence was not sufficient in September 1998, was there sufficient 
evidence available to Greece in August 2003  to permit it to undertake a more 
objective assessment of potential risks to human, plant and animal health, and 
the environment from the import and processing of oilseed rape Topas 19/2 
(EC-162/At.6  to 13)?  If not, what scientific evidence do you believe was insufficient?   
123. The experts agree that the Greek prohibition on the importation of oilseed rape Topas 19/2 is 
not scientifically justified. 
124. Although Dr. Andow asserts that Greece's thir d reason for banning Topas 19/2 (increased 
difficulty in managing farmland because GMHT oil seed rape winters better in Greece and could 
spread faster and is hard to eliminate once establis hed as a weed) has some merit as a risk, he also 
notes that risk management options other than a ban are available to address this problem.125 
125. Dr. Andow also suggests that there were othe r arguments that Greece could have made to 
support the ban in 1998 on grounds of insufficient sci entific evidence to comple te a risk assessment.  
He does not specify what the insufficiencies were, but , in any event, he concludes that, had Greece 
collected the necessary data, it would have been ab le to make a decision by 2001 at the latest.126 
126. Again, Dr. Snow is unequivocal in rejecting the idea that Greece did not have sufficient 
scientific evidence available to it  to complete a risk assessment.127  Dr. Snow indicates that she does 
not understand why Greece assumes feral populations  would become established or why they would 
become environmental problems, and that even if  such populations became established there is no 
scientific reason to expect that gene flow would harm the genetic diversity or abundance of wild 
relatives.128 
67. With reference to the definition of a risk assessment in the SPS Agreement (see 
Background above), to what extent does the scientific evidence and other documentation 
submitted by Greece evaluate the relevant risk s to human, plant or animal health, and the 
environment from the import and processi ng of oilseed rape Topas 19/2?   
 
                                                      
125 Andow, p. 87. 
126 Ibid., pp. 87-88. 
127 Snow, p. 27. 
128 Ibid. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-64 
  
 (a) How does the scientific evidence and oth er documentation submitted by Greece 
compare with the relevant internationa l guidelines for risk assessment and 
analysis identified above? 
127. Dr. Andow is of the view that Greece faile d to follow the requirements of either the SPS 
Agreement or ISPM No.11 but that the science, reasoning and documentation of Greece was 
consistent with Annex III of the BSP.129  As was noted earlier, Canada is of the view that Annex III of 
the BSP does not constitute an international standard or guideline as those terms are defined in the SPS Agreement .  
128. Dr. Snow repeats her answers to questions 63-66.130 
68. Does the scientific evidence and other info rmation submitted by Greece support the 
adoption of a temporary prohibition on the import  and processing of oilseed rape Topas 19/2?  
In light of any potential risks identified by Greece, what other risk management options were available in September 1998?  What other risk management options are now available? 
 
129. The experts agree that the Greek import prohibition is not scientifically justified,131 although 
Dr. Andow appears to be of the view that it was scientifically justified in 1998. 
130. The advice of the experts supports the argumen t that the Greek import prohibition cannot be 
justified on the basis of scientific evidence. 
Maize MON 810 (notification C/F/95/12-02)  
 
Safeguard measure of Italy 
 
78. Given the information before the Panel, in cluding the evaluations undertaken by France 
(EC-159/At.1 and 2); and the Scientific Comm ittee on Plants in February 1998 (CDA-82), 
September 1999 (US-55), and September 2000 (CDA- 86), and the European Commission in its 
Decision of April 1998 (CDA-81), as well as the information submitted by Italy with respect to its safeguard measure (EC-157/At. 1 and 2, CDA-78) , is there any reason to believe that the 
scientific evidence available to Italy in August 1988 was NOT sufficient to permit it to undertake an appropriate assessment of potential risks to human, plant and animal health, and the 
environment from Maize MON 810?  If so, what scientific evidence do you believe was 
insufficient?   
 
(a) If the evidence was not sufficient in August 1988, was there sufficient evidence 
available to Italy in August 2003  to permit it to undertake a more objective 
assessment of potential risks to human, plant and animal health, and the environment from Maize MON 810?  If not, what scientific evidence do you 
believe was insufficient? 
131. Dr. Nutti indicates in her reply that the informa tion provided by the applicant covered all the 
items needed for the comparison of the GM maize and its conventional counterpart.132  According to 
                                                      
129 Andow, p. 88. 
130 Snow, p. 27. 
131 Andow, p. 88; Snow, p. 27. 
132 Nutti, p. 58.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-65 
 
 
 her, the variation in the levels of protein was in the range of natural variation so the point raised by 
Italy regarding protein levels was not correct.133 
132. In conclusion, Dr. Nutti states that "there is NO reason to believe that the scientific evidence 
available to Italy in August [1998] was NOT suff icient to permit it to undertake an appropriate 
assessment of the potential risks to human, pl ant and animal health…from Maize MON810".134 
133. The expert's advice is fully consistent with th e argument that the Italian ban on MON810 was 
not scientifically justified. 
79. With reference to the definition of a risk assessment in the SPS Agreement (see 
Background above), to what extent does the scientific evidence and other documentation 
submitted by Italy evaluate the relevant risk s to human, plant or animal health, and the 
environment from Maize MON 810? 
 
(a) How does the scientific evidence and oth er documentation submitted by Italy 
compare with the relevant internationa l guidelines for risk assessment and 
analysis identified above? 
134. Dr. Nutti indicates that the information for the safety assessment provided by the applicant 
and evaluated by France and the SCP and SCF were adequate and in accordance with Codex 
guidelines.135  In contrast, the information and arguments submitted by Italy were not.136 
135. In this regard, also, the expert's advice is fully  consistent with the argument that there is a 
virtually complete absence of scientific justification for Italy's ban on MON810. 
80. Does the scientific evidence and other in formation submitted by Italy support the 
adoption of a temporary prohibition on Maiz e MON 810?  In light of any potential risks 
identified by Austria, what other risk management options were available in August 1988?  What other risk management options are now available? 
 
136. Dr. Nutti concludes that the scientific ev idence submitted by Italy does not support a 
temporary prohibition on Maize MON810.137 
137. The expert's advice supports Canada's position. 
Maize T25 (notification C/F/95/12-07)  
 
Safeguard measure of Austria 
 
84. Given the information before the Panel, in cluding the evaluations undertaken by France 
(EC-160/At.1 and 2); the Scientific Committee  on Plants in September 2000 (CDA-75) and 
September 2001 (CDA-86 and CDA-77), and the European Commission in its Decision of April 
1998 (CDA-74), as well as the information submitted by Austria with respect to its safeguard 
measure (EC-160/At.3 and 5, CDA-76, EC-144, EC- 153), is there any reason to believe that the 
                                                      
133 Ibid. 
134 Ibid. 
135 Nutti, p. 58 
136 Ibid. 
137 Nutti, p. 59. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-66 
  
 scientific evidence available to Austria in April 2000 was NOT sufficient to permit it to 
undertake an appropriate assessment of potential risks to human, plant and animal health, and the environment from Maize T25?  If so, what scientific evidence do you believe was 
insufficient?   
 
(a) If the evidence was not sufficient in April 2000, was there sufficient evidence 
available to Austria in August 2003  to permit it to undertake a more objective 
assessment of potential risks to human, plant and animal health, and the 
environment from Maize T25 (EC-158/At.30-42)?  If not, what scientific 
evidence do you believe was insufficient?   
138. Dr. Nutti states that, based on the information presented by the notifier and the scientific 
evaluation undertaken by France and by the SCP, th ere is no reason to believe that the scientific 
evidence available to Austria in  1999 was insufficient to allow it to undertake an appropriate 
assessment of potential risks to human, plant and animal health from maize T25.138 
139. From the standpoint of environmental risks, according to Dr. Andow, Austria presented six 
reasons for its safeguard measure: 
− environmental risks had not been sufficien tly evaluated under realistic conditions; 
− no post-commercialization program; 
− potential risk of harm from pollen transfer, though likely absent, should be monitored; 
− no measures to protect ecologically sensitive areas; 
− a need for "good farming practice" guidelines to minimize risk of resistance; and 
− the need to assess long-term and secondary ecological effects.139 
 
140. Dr. Andow says (1), (3), (5) and (6) present possible justification for the safeguard measure.  
He then discards (6) on the grounds that assessing lo ng-term effects is impossible in pre-commercial 
assessments.  He discards (3) on the grounds that Austria does not specifically identify the possible 
harm.  He also dismisses (1) on the grounds that Au stria does not provide any scientific evidence that 
such harms might exist, with the ex ception of resistance risk.  Notably, he says that "a risk assessment 
cannot be considered insufficient if a ll concrete possible risks are addressed".140 
141. This leaves only the issue of the evolution of resistance in weeds as a secondary 
environmental effect.  Dr. Andow says that the amended SCP opinion (CDA-77) does not provide an 
assessment of this risk even thoug h resistance risks are widely recognized and the consistent use of 
glufosinate with T25 would result in such a risk.  Thus, according to Andow, "there was insufficient scientific evidence available to the SCP and Austria to  assess weed resistance risk and appropriate risk 
management measures."
141 
142. Dr. Andow acknowledges, however, that managing resistance risk in maize should be easier 
than for oilseed rape, and says that adequate information for a risk assessment would have been available by 2003 had the parties made concerted efforts to bring it together.
142  However, it is not 
clear to Canada what the environmental risk is, or why adequate information to complete a risk 
                                                      
138 Ibid. p. 60. 
139 Andow, p. 110. 
140 Ibid. pp. 111-12. 
141 Ibid. 
142 Ibid.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-67 
 
 
                                                      assessment would not have been av ailable until 2003.  Clearly, resistance management strategies were 
well-understood and practised before 2003.  
143. Dr. Andow then goes on to offer his views on shifting evidentiary standards for what 
constitutes an objective environmenta l risk assessment, particularly in  relation to the molecular basis 
of transformation, and regarding the emergence of contamination of conventional production as 
possible new grounds for the safeguard measure.  He  concedes that scientific evidence to support risk 
management measures to address the coexistence "ris k" were available in 2003, and concludes that 
Austria could also argue that T25 was "inadequately characterized". 
144. In reality, Dr. Andow's focus on the possible emergence of resistant weeds as an 
environmental risk – and, moreover, one that coul d not be adequately addressed until 2003 – flies in 
the face of the fact that the emergence of herbicide resistance is an endemic issue wherever herbicides 
are used.  Furthermore, the herbicide in ques tion – glufosinate-ammonium – has proved to be 
remarkably resilient when it comes to the emergence of resistance.  Despite extensive use, there is no 
recorded case of weeds becoming resistant to this herbicide. 
145. Canada also fails to understand Dr. Andow's comme nt that, "in 2003, Austria could also argue 
that T25 was inadequately characterized."143  The fact that molecular characterization techniques may 
have improved in the intervening years between the Community-wide approval of T25 in 1998 and 
2003, to argue five years after the fact that mol ecular characterization was inadequate while relying 
on technology that did not even exist at the time the product was approved is to invite the perpetual delay of product approvals.  The question has to be as ked, is there a valid scientific reason to do so in 
absence of a demonstrable risk. 
85. With reference to the definition of a risk assessment in the SPS Agreement (see 
Background above), to what extent does the scientific evidence and other documentation 
submitted by Austria evaluate the relevant risks to human, plant or animal health, and the 
environment from Maize T25? 
 
(a) How does the scientific evidence a nd other documentation submitted by 
Austria compare with the relevant intern ational guidelines for risk assessment 
and analysis identified above? 
146. Dr. Nutti is of the view that the information for the safety assessment of potential risks to 
human and animal health that was submitted by applicants and evaluated by French CA met 
international guidelines (Codex) wa s adequate and in accordance with the relevant international 
standard.144   
147. Dr. Andow expresses doubt that Austria's scientific  evidence and other information meets the 
requirements of the SPS Agreement  or ISPM No. 11, but he is of the view that it is "probably" 
consistent with the Annex III of the BSP.145 
86. Does the scientific evidence and other in formation submitted by Austria support the 
adoption of a temporary prohibition on Maize T25?  In light of any potential risks identified by 
Austria, what other risk management option s were available in April 2000?  What other risk 
management options are now available? 
 
143 Ibid. 
144 Nutti, p. 60. 
145 Andow, p. 112-13. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-68 
  
  
148. Dr. Nutti says that, from the perspective of food and feed safety, the Austrian prohibition on 
maize T25 was not scientifically justified.146 
149. Dr. Andow says that the adoption of the prohib ition was "probably" not justified on the basis 
of the scientific evidence and other information provided by Austria.147  At the same time, he claims 
that "a temporary prohibition probably c ould have been justified at the time because the appropriate 
scientific information did exist".148  Dr. Andow does not specify to what "appropriate scientific 
information" he is referring, nor does he indicate th e nature of the risk to which that information 
would pertain.  Without knowing this, Canada is not in a position to comment on Dr. Andow's 
response. 
150. In the following paragraph, Dr. Andow offer the opinion that "several other risk management 
options could also have been justified in April 2000", focusing on the resist ance risk, and suggests a 
few.149  It is not clear what distinction Dr. Andow draws between "risk mitigation" and "risk 
avoidance".  What is clear is that well-understood, scientifically ve rified risk management measures 
did exist in 2000 to address any concerns about weed  resistance that Austria might have had at that 
time, including proper crop and herbicide management.  In any event, the evolution of resistant weeds 
is only an issue if (1) the weed is economically important, and (2) no other suitable, sustainable control measures exist (e.g., altern ative herbicide applications). 
Safeguard measure of Italy 
 
87. Given the information before the Panel, in cluding the evaluations undertaken by France 
(EC-160/At.1 and 2);  the Scientific Committ ee on Plants in September 2000 (CDA-75) and 
September 2001 (CDA-86 and CDA-77), and the European Commission in its Decision of April 1998 (CDA-74), as well as the information submitte d by Italy with respect to its safeguard 
measure (CDA-78, EC-157/At. 1 and 2), is there any reason to believe that the scientific evidence available to Italy in August 1988 was NOT sufficien t to permit it to undertake an appropriate 
assessment of potential risks to human, plant and animal health, and the environment from 
Maize T25?  If so, what scientific eviden ce do you believe was insufficient?   
 
(a) If the evidence was not sufficient in August 1988, was there sufficient evidence 
available to Italy in August 2003  to permit it to undertake a more objective 
assessment of potential risks to human, plant and animal health, and the environment from Maize T25?  If not, wh at scientific evidence do you believe 
was insufficient?   
151. Dr. Nutti indicates that there is no reason to belie ve that the scientific evidence available to 
Italy in August 2000 was insufficient to allow an appropriate assessment of potential risks to human, 
plant and animal health from maize T25.150 
152. The expert's advice supports Canada's position th at there was no scientific reason for Italy to 
impose a prohibition on maize T25 for food and feed. 
                                                      
146 Nutti, p. 61. 
147 Andow, p. 113. 
148 Ibid. 
149 Ibid. 
150 Nutti, p. 62.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
 WT/DS293/R/Add.7 
 Page I-69 
 
 
 88. With reference to the definition of a risk assessment in the SPS Agreement (see 
Background above), to what extent does the scientific evidence and other documentation 
submitted by Italy evaluate the relevant risk s to human, plant or animal health, and the 
environment from Maize T25? 
 
(a) How does the scientific evidence and oth er documentation submitted by Italy 
compare with the relevant internationa l guidelines for risk assessment and 
analysis identified above? 
153. Dr. Nutti concludes that the scientific evid ence submitted by Italy does not meet the 
requirements of the relevant international guidelines (Codex).151 
89. Does the scientific evidence and other in formation submitted by Italy support the 
adoption of a temporary prohibition on Maize T25?  In light of any potential risks identified by Italy, what other risk management options were available in August 1988?  What other risk 
management options are now available? 
 
154. Dr. Nutti is of the view that the scientific evidence submitted by Italy does not support a 
temporary prohibition on GM maize T25.152 
155. The expert's advice supports Canada's position. 
Maize MON 809 (notification C/F/95/12-01/B)  
 
Safeguard measure of Italy 
 
90. Given the information before the Panel, including the evaluations undertaken by the 
Scientific Committee on Plants in May 1998 and September 2000 (CDA-85 and CDA-86), as well 
as the information submitted by Italy with respect to its safeguard measure (CDA-78, 
EC-157/At. 1 and 2), is there any reason to believe that the scientific evidence available to Italy in August 1988 was NOT sufficient to permit it to undertake an appropriate assessment of potential risks to human, plant and animal health, and the environment from Maize MON 809?  If so, what scientific evidence do you believe was insufficient?   
 
(a) If the evidence was not sufficient in August 1988, was there sufficient evidence 
available to Italy in August 2003  to permit it to undertake a more objective 
assessment of potential risks to human, plant and animal health, and the environment from Maize MON 809?  If not, what scientific evidence do you believe was insufficient?   
156. Dr. Nutti indicates that the information submitte d by the applicant covered all the items 
needed for the comparison of the GM maize and its conventional counterparts, not only for with data on nutrients, but also with animal feeding studies.
153  The variation in levels of protein was in the 
range of natural variation, so Italy's point concerning protein levels was not correct.  She concludes that "there is NO reason to believe that the scientif ic evidence available to Italy in August [2000] was 
                                                      
151 Ibid., p. 63. 
152 Ibid. 
153 Nutti, p. 64. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
WT/DS293/R/Add.7 
Page I-70 
  
 NOT sufficient to permit it to undertake an appropria te assessment of potential risks to human, plant 
and animal health".154 
157. In this regard, the expert's advice supports the position of Canada that Italy was not 
scientifically justified in imposing a safeguard measure on precautionary grounds. 
91. With reference to the definition of a risk assessment in the SPS Agreement (see 
Background above), to what extent does the scientific evidence and other documentation 
submitted by Italy evaluate the relevant risk s to human, plant or animal health, and the 
environment from Maize MON 809? 
 
(a) How does the scientific evidence and oth er documentation submitted by Italy 
compare with the relevant internationa l guidelines for risk assessment and 
analysis identified above? 
158. Dr. Nutti says that the information submitted by the applicants and evaluated by the French 
CA met the requirements of international guidelin es (Codex).  In contrast , "the information and 
arguments provided by Italy were not in accordance with those guidelines."155 
92. Does the scientific evidence and other in formation submitted by Italy support the 
adoption of a temporary prohibition on Maiz e MON 809?  In light of any potential risks 
identified by Italy, what other risk management options were available in August 1988?  What other risk management options are now available? 
 
159. Dr. Nutti says that the scientific evidence su bmitted by Italy does not support a temporary 
prohibition of GM Maize MON 809.156  As noted earlier, Dr. Nutti's expert advice supports Canada's 
position in this regard. 
Maize Bt-11 (reference C/GB/96/M4/1)  
 
Safeguard measure of Italy 
 
93. Given the information before the Panel, in cluding the evaluations undertaken by Great 
Britain (EC-163(At.1 to 3), the Scientific Comm ittee on Plants in February 1998 (CDA-83), 
November 2000 (CDA-84), and April 2002 (CDA-35-J), and the European Commission in its 
Decision of April 1998 (CDA-80),  as well as the in formation submitted by Italy with respect to 
its safeguard measure (CDA-78, EC-157/At. 1 and 2) , is there any reason to believe that the 
scientific evidence available to Italy in August 1988 was NOT sufficient to permit it to undertake 
an appropriate assessment of potential risks to human, plant and animal health, and the 
environment from Maize Bt-11?  If so, what scienti fic evidence do you believe was insufficient?   
 
(a) If the evidence was not sufficient in August 1988, was there sufficient evidence 
available to Italy in August 2003  to permit it to undertake a more objective 
assessment of potential risks to human, plant and animal health, and the environment from Maize Bt-11?  If not, what scientific evidence do you believe 
was insufficient?   
                                                      
154 Ibid., pp. 64-65 (emphasis in the original). 
155 Ibid., p. 65. 
156 Ibid., p. 65.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 160. Dr. Nutti says that that information submitted by  the applicant covered all the items needed 
for the comparison of the GM maize and its conven tional counterpart, not only with data on nutrients 
but also with animal feeding studies.  The variation in levels of protein was not statistically 
significant, so Italy's point about protein levels was not correct.157 
161. She concludes that there is no reason to believe that the scientific evid ence available to Italy 
in August 2000 was insufficient to permit an appropriate assessment of  potential risks to human, plant 
and animal health from GM maize Bt11. 
162. Dr. Nutti's advice supports the argument that Italy was not scientifically justified in imposing 
a safeguard measure banning maize Bt11 in food and feed on precautionary grounds. 
94. With reference to the definition of a risk assessment in the SPS Agreement (see 
Background above), to what extent does the scientific evidence and other documentation 
submitted by Italy evaluate the relevant risk s to human, plant or animal health, and the 
environment from Maize Bt-11? 
 
(a) How does the scientific evidence and oth er documentation submitted by Italy 
compare with the relevant internationa l guidelines for risk assessment and 
analysis identified above? 
163. According to Dr. Nutti, the information subm itted by the applicant met all requirements of 
international guidelines (Codex).  In contrast, the information and arguments of Italy did not meet 
those requirements.158 
95. Does the scientific evidence and other in formation submitted by Italy support the 
adoption of a temporary prohibition on Maize Bt- 11?  In light of any potential risks identified 
by Italy, what other risk management options were available in August 1988?  What other risk management options are now available? 
 
164. Dr. Nutti concludes that the scientific ev idence submitted by Italy does not support a 
temporary prohibition on GM maize Bt11.159 
165. The expert's advice supports the argument th at the Italian ban on maize Bt11 was not 
scientifically justified. 
ISSUE 3  
 
Products of biotechnology approved by th e European Communities prior to October 1998 
 
96. Has there been a significant change in the understanding of physical, chemical and biological characteristics of biotech products, gene interactions, gene expression, gene silencing, 
molecular characterization, and pr oduct specific detection since 1998? 
 
166. Canada has no comments on the responses to th is question by Drs. Squire and Nutti. 
                                                      
157 Ibid., p. 67. 
158 Nutti, p. 68. 
159 Ibid. WT/DS291/R/Add.7 
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 97. On the basis of the information before the Panel, is there new scientific evidence since 
1998 that would suggest that the potential risks to human, plant or animal health, or to the 
environment, from any of the specific biotech products subject to this dispute (including 
products subject to the member State safegu ard measures), are different in nature or 
magnitude as compared to the scientific understandi ng of the risks associated with such biotech 
products prior to 1998, taking into account: 
 
• the intended use of each product (direct human or animal consumption, further 
processing for consumption, planting or any other specified use); 
 
• any potential risks that may arise from the combination or successive use of biotech products.  
 
Does the information before the Panel support th e view that the potential risks from the 
products in this dispute should be assessed differently than the risks from biotech products 
approved prior to 1998?  
167. Canada notes that this question concerns whether or not the risks associated with biotech 
products approved prior to 1998 are different in natu re or magnitude to those biotech products that 
have been in the approval process since 1998 ( i.e. those products subject to the moratorium ).  With 
some exceptions, the biotech products approved prior to the implementation of the moratorium  are 
either Bt crops or crops resistant to glyphosate and glufosinate-ammonium.  The biotech products subject to this dispute are substantially the same of those approved prior to 1998 – namely, Bt crops 
and glyphosate and glufosinate-ammonium tolerant crops.  
168. It appears that Drs. Andow, Snow and Squire did not address the issue of whether the risks 
between these two categories of products are different in nature or magnitude.  The experts discuss the 
development of new scientific information (e.g. gene flow amongst HT crops, potential impact on 
non-target organisms of Bt crops), but this new in formation applies equally to biotech crops approved 
prior to 1998 and those subject to the moratorium.   Similarly, Dr. Andow discusses changes in the 
approaches to risk assessment and management, but while these changes may have led to refinements in assessment and management procedures, they ha ve not revealed differences in the nature and 
magnitude of risks as between the two categories of products.  Risks of the development of resistance 
in pests to Bt toxins or the development of resi stance to herbicides apply equally to all these products. 
169. Consequently, as the biotech products subject to the moratorium  are substantially the same as 
those approved prior to 1998, the nature and magnit ude of the risks between the two categories are no 
different.   
170. With respect to food and feed, Dr. Nutti concl udes that there is no new evidence that would 
suggest potential risks are different in nature or  magnitude as between products approved prior to 
1998 and those subject to the moratorium . 
171. In terms of the specific issues raised by the e xperts, Canada directs the Panel to Canada's 
comments on Questions 2 through 8. 
98. From a scientific perspective, is there a significant difference in risks to human, animal or plant health or the environment arising from the use of a bacterial antibiotic resistance 
marker gene, or part thereof, in any biotech product at issue in this dispute (eg, Monsanto Bt 
cotton (531), Monsanto Roundup Ready cotto n (RRC1445), Amylogene starch potato)  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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                                                      compared to those products of biotechnology ap proved by the European Communities prior to 
October 1998? 
 
172. Dr. Nutti states that, from a food and feed perspective, based on the existing literature and 
knowledge of the subject, and from a scientific pers pective, there is no ne w evidence that would 
suggest that the potential risks to human, animal or  plant health arising from the use of a bacterial 
antibiotic resistance marker gene, or part thereof, from any biotech product at issue in this dispute are 
different in nature or magnitude as compared to those products of biotechnology approved by the 
European Communities prior to October 1998.160 
99. For those biotech products at issue in th is dispute for which no significantly different 
nature or level of risk has been identified, do es the information before the Panel provide a 
scientific or technical rationale for monitoring the occurrence of potential adverse effects, or of 
unintentional effects, arising from the consumption or use of these products compared to those products of biotechnology approved by the European Communities prior to October 1998? 
 
173. Dr. Snow asserts that "with regard to environmental effects, if this question pertains only to 
products that have no identif ied environmental risks, then there is  no scientific rationale for obligatory 
monitoring."  Moreover, it is not lo gical to require monitoring of ev ery transgenic crop, regardless of 
its phenotypic traits.  Dr. Snow concludes that "s pecific and plausible envi ronmental harms should be 
identified before allocating time and mone y to these efforts."  Canada agrees. 
174. Dr. Nutti concludes that the products at issue s hould be treated the same as biotech products 
approved prior to 1998. 
175. Only Dr. Andow attempts to construct an ar gument for imposing monitoring on post-1998 
products and not pre-1998.  First, he appears to suggest that disagreements amongst Member States 
concerning risks would justify monitoring.  Sec ond, Dr. Andow states that "[a]ll of these possible 
sources unanticipated [sic] effects are equally likel y to occur for plant biotech products before 1998 
and plant biotech products after 1998.  It is possible that more recent events (after 2001) are less likely 
to have such unanticipated effects than those prior to 1998."161  Dr. Andow then asserts that changes 
in methods and standards for assessing the possibilities of unanticipated effects justifies monitoring.  
However, by his own logic, it would appear to make  as much sense, if not more, to impose monitoring 
requirements on pre-1998 biotech products. 
100. For those biotech products at issue in this dispute for which an approval has been sought for environmental release (notifications submitted under Directives 90/220 or 2001/18), and for which no significantly different nature or  level of risk has been identified, does the 
information before the Panel provide a scientific or technical rationale for requiring specific 
agricultural management practices that differ from those for products of biotechnology approved by the European Communities prior to October 1998?   
 
176. Dr. Squire states that while the "innate biological qualities and behaviour of a product may 
not have changed", it is possible the context with in which the product operates may have.  He cites 
changes in the physical or agronomic environmen t, such as the proportion of autumn-sown crops, the 
area covered by oilseed rape and the increase in the use of certain pesticides (glyphosate).  He also indicates that our understanding of the GM product's ro le in the ecosystem has changed.  What was 
not thought to be important at that  time is considered important now. 
 
160 Nutti, p. 72. 
161 Andow, para. 99.04. WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
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                                                      177. Canada submits that, while changes in contex t may require an adjustment in agricultural 
management practices, there is no reason to limit any such changes to post 1998 biotech products.  
For instance, if management measures for effectivel y controlling the spread of herbicide-resistance 
become necessary due to changes in cont ext, these measures should be adopted for all  HT plants in 
cultivation.  
101. Does the information before the Panel suppo rt the argument that any potential risks 
from any of the biotech products at issue in this dispute should be mitigated in a manner 
different than the products of biotechnology approved by the European Communities prior to 
October 1998?  If so, what means of risk mitigation might be envisaged? 
 
178. Dr. Squire states that, while products may have  very similar qualities, mitigation might differ 
as a result of new information informing risk or a new perception of the importance of a particular 
risk.  The perceived need to reduce the "severity" of a risk to biodiversity and ecosystem functioning 
has changed because of a greater appreciation that arable systems have been affected by intense 
agriculture.  The general thrust of Dr. Squire's re sponse is that mitigation measures should evolve to 
meet changing circumstances and new information.  Canada agrees.  However, this would apply equally to pre-1998 products. 
179. Dr. Snow states that several of the products that were approved before 1998 are the same or 
similar to those in this dispute.  She lists several  oilseed rape and maize varieties approved prior to 
1998.  She then postulates that the answer to the question hinges on which potential environmental risks might require mitigation, and whether any new scientific knowledge has become available to 
justify changes to any mitigation plans that were required prior to 1998.  She then points to new 
knowledge relating to gene flow (in the context of HT oilseed rape) and the evolution of resistance in 
target pests of Bt crops.  She also notes that in the case of oilseed rape approved for import and 
processing only, she cannot see any new scientific reasons for different mitigation plans as between products approved prior to 1998, and those subject to the dispute ( e.g. GT73). 
180. Canada notes that even if new information came to light concerning the risks associated with 
Bt or HT crops, the mitigation measures to addr ess these new risks should apply equally to pre-1998 
Bt and HT crops.  Indeed, Directive  2001/18 specifically provides for the reconsideration of the 
original consent by the EC in the event of "new or additional information made available since the 
date of the consent and affecting the environmental risk assessment."162  However, in no cases of pre-
1998 approved products, has the EC revoked, rescinded or modified, the original consent. 
Comparable novel non-biotech products, (such as plant products produced by selective breeding, cross-breeding and induced mutagenesis) 
 
102. Does the information before the Panel support  the view that the biotech products at 
issue in this dispute (including products subject  to the member State safeguard measures) give 
rise to the same types of potential risks to human , plant or animal health or to the environment 
as novel non-biotech products, such as plant products produced by selective breeding, cross-
breeding and induced mutagenesis?  If so, for any biotech product at issue in this dispute are there significant differences, from a scientific pe rspective, in the nature or magnitude of any 
potential risks from these products compared to  comparable novel non-biotech products taking 
into account: 
 
• the specific genetic modification introduced and the resulting product; 
 
162 Directive 2001/18 , Art. 23.  WT/DS291/R/Add.7 
 WT/DS292/R/Add.7 
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 Page I-75 
 
 
  
• the intended use of each product (direct human or animal consumption, further 
processing for consumption, planting or other use); 
 
• any potential risks that may arise from the combination or successive use of biotech products or comparable  novel non-biotech products. 
 
Please explain with reference to specific products at issue in this dispute. 
 
181. Drs. Nutti, Snow and Andow respond to this  question.  Dr. Nutti indicates that novel non-
biotech products have not been subject to any ex tensive safety assessment, and she is of the opinion 
that both novel non-biotech products and biotech products should be assessed in a comprehensive, 
scientific, step-by-step, case-by-case basis, so the same safety assessment principles should be applied 
in all cases.  She appears to share the widely he ld consensus that the technology used to develop 
biotech products does not give rise to different potential risks to human and animal health. 
182. On the other hand, Dr. Snow suggests th at biotech products in this dispute " could be 
considered as different from non-bi otech novel products in some cases ."  Dr. Snow cites as an 
example glyphosate-tolerant crops.  She says that glyphosate resistance has not been introduced into 
crops using non-transgenic methods, so this particular  trait is linked solely to novel transgenic crops.  
She suggests that extensive use of  glyphosate could lead to weedy Brassica rapa populations that 
have acquired the trangene through gene flow to become more common in and around farmers' fields.  
She speculates about this transfer of resistance could occur to many types of crops.  However, she 
then says "[t]hese problems are possible with all types of herbicide-tolerant crops" but "unique 
features of glyphosate make it a special case".  Thus, Dr. Snow appears to acknowledge that the same types of potential risks to human, plant, animal heal th or to the environment exist for all HT crops, 
regardless of the technology used.  However, she di stinguishes one type of HT crop on the basis that 
the herbicide to which the crop is tolerant is widely used.  This may be an argument for why 
glyphosate-tolerant crops require more robust mana gement procedures, but it is not an argument for 
why biotech HT crops are different from non-biotech HT crops.  Unfortunately, Dr. Snow does not discuss in any detail the types of potential risks to hu man, plant or animal health or to the environment 
from other biotech HT crops tolerant ( e.g. those tolerant to glufosinate-ammonium) or non-biotech 
HT crops developed through mutagenesis ( e.g. those tolerant to imidazolinone). 
183. Dr. Andow acknowledges that there are no differences in the types or kinds of risks posed by 
biotech crops as compared to their non-biotech counterparts: toxicity to humans and animals; 
allergenicity; nutritional qualities; potential fo r producing disease; gene flow; non-target and 
biodiversity risks; and resistance risks.  However, he claims that within these risks, there are new 
kinds of risks associated with biotech plants. 
184. Dr. Andow asserts that transgenesis does not allow more precise control than selective 
breeding.  According to Dr. Andow, because both transgenic and conven tional varieties undergo 
selective breeding, the comparison is inappropriate.  However, while both undergo selective breeding, 
it is for different purposes.  In the former case, th e selective breeding is random, through mutagenesis, 
chance mutation or the introduction of new germplasm in order to achieve a desired phenotype; in the 
latter, the selective breeding involves the introduc tion of the transgene into an "elite" germplasm 
background; thus the breeding is usuall y into well established well-adapted lines. 
185. Dr. Andow claims the magnitude of the open reading frames (ORF) and insertional 
mutagenesis introduced by transgenesis is higher than  that for adapted materials.  It may also be 
higher than deliberate or spontaneous mutations in  cell culture, though Dr. Andow is less certain on WT/DS291/R/Add.7 
WT/DS292/R/Add.7 
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                                                      this point.  However, the presence of an open reading frame is not the issue; the issue is whether there 
is an expressed protein.  Furthermore, these typ es of effects would be eliminated by subsequent 
breeding during the development of the product, and the risk of new open reading frames and 
chimeric proteins is effectively addressed during the molecular characterization. 
186. Unfortunately, Dr. Andow does not compare the ri sks associated with induced mutagenesis to 
the risks associated with biotech products. 
103. Does the information before the Panel support the view that any of the biotech products 
at issue in this dispute poses a substantially greater risk as regards the direct or indirect 
consequences of unintentional "contamination" of other plant varieties than a comparable novel 
non-biotech products, such as one of the 2300 different crop varieties that have been developed 
using induced mutagenesis?163  If so, what means of risk mitigation might be envisaged? 
 
187. Dr. Squire does not appear to answer the sp ecific question posed, which focuses on the risks 
arising from contamination rather than the risk of contamination. 
188. In any event, he observes that a certain le vel of impurity seems to have been generally 
accepted for many years.164  The specific level of impurity varied from crop to crop.  Impurity is 
common in oilseed rape, less common in beet and ma ize.  The potential for a crop variety to convey 
an impurity depends on several factors, such as  the proportion of seeds that enter dormancy, the 
persistence of seeds in the soil, and the relative polle n strength of potential donor and recipient fields.  
Dr. Squire indicates that these factors may differ between GM and non-GM varieties but should not 
differ because one is GM and the other not.  He concludes that there is no reason to suppose that biotech crops confer different degrees of impurity compared with crops produced from, say, induced mutagenesis.
165 
189. Dr. Snow also appears not to give a definitive answer to the specific question asked.  She 
suggests that the answer depends on "what types of risks each party is trying to avoid".166  According 
to her, if standard thresholds have been established to allow for coexistence, then by definition contamination is an issue for all biotech products.  In Canada's view, the qu estion then becomes what 
is the nature of the risk that would arise from that contamination. 
190. Dr. Snow also notes that labelling and traceability have not been required for novel non-
biotech products such as those developed usin g mutagenesis, nor would any high-resolution 
identifying markers be availa ble for these types of crops.167 
191. She says another way to answer this question is to focus on phenotypes; this is more 
appropriate if the goal is to avoid direct or indir ect harm to human, plant or animal health, or the 
environment.168   She points to Part I of her answers, and her answer to Question 6 "for examples of 
risks that are greater in certain GM crop s as compared to their non-GM predecessors",169 but recourse 
to these passages does not appear to provide any substantially greater cl arity in terms of a response to 
the specific question asked. 
 
163 FAO/IAEA (Food and Agriculture Organization of the United Nations/International Atomic Energy 
Agency). 2001. FAO/IAEA Mutant Varieties Database.  Available online at http ://www-infocris.iaea.org/MVD/. 
164 Squire, p. 17. 
165 Ibid. 
166 Snow, p. 33. 
167 Ibid. 
168 Ibid. P. 34. 
169 Ibid.  WT/DS291/R/Add.7 
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                                                      192. Dr. Andow says it depends on the scale of release and the nature of the adverse effect.170  
Furthermore, the definition of an adverse effect entails specification of whom or what will be affected 
and how is this effect considered adverse.  He a dds further complexity when he notes that "there has 
been little discussion and less agreement over the nature  of the adverse effects of contamination", and 
muses that "it is not clear to [him ] that there is agreement that these kinds of perceived risks should be 
considered."171 
193. Dr. Andow then posits that an organic farmer  might find contamination to be an adverse 
effect because of the economic impact. Dr. Andow says that in this example at least, the risk 
associated with biotech crops is substantially gr eater than the risk associated with conventional 
varieties (based on the definition of harm).172  However, Canada does not understand why this would 
be true.  Whether an organic crop is contaminat ed with a transgenic seed or a conventional non-
organic seed ought not to matter provided that the risks to human or animal health or the environment are the same. 
194. In short, none of the three experts on environmental risks appear to have a clear or 
unequivocal answer to the question as posed.  Of c ourse, the question does not specify what it means 
when it uses the term "risk"; is it confined to ri sks of environmental harm, or harm to human or 
animal plant life or health?  Does it encompass what might be called pure economic loss?  It may be that the ambiguity of the question prevented the experts from expressing themselves clearly and 
unequivocally. 
195. In contrast, Dr. Nutti is of the firm view that  crop varieties that have been developed using 
induced mutagenesis can pose the same risks to human or animal health as plants produced from 
Recombinant-DNA technology, and should be assessed in the same manner.173 
104. From a scientific perspective, is there a sign ificant difference in risks to human, animal 
or plant health or the environment arising from the use of a bacterial antibiotic resistance 
marker gene, or part thereof, in any biotech product at issue in this dispute (eg, Monsanto Bt 
cotton (531), Monsanto Roundup Ready cotto n (RRC1445), Amylogene starch potato) 
compared to novel non-biotech products, such as comparable plant products produced by selective breeding, cross-breeding and induced mutagenesis? 
 
196. Dr. Nutti indicates that the use of antibiotic resistance marker genes has been recognized as a 
safe tool and its employment should be evaluated on a case by case basis.  The same rule should be applied to novel non-biotech products, such as comparable plant products produced by selective breeding, cross-breeding and induced mutagenesis.
174 
105. For those biotech products at issue in this dispute for which no significantly different nature or level of risk has been identified, is there a scientific or technical rationale for 
monitoring the occurrence of pote ntial adverse effects, or of unintentional effects, arising from 
the consumption or use of these products compared  to novel non-biotech products, such as plant 
products produced by selective breeding, cross-bree ding and induced mutagenesis?  If so, would 
such monitoring relate to the specific genes or tr aits introduced into a biotech product, and how 
would this compare with the monitoring of induced changes in novel non-biotech products?  
 
170 Andow, p. 127. 
171 Ibid. 
172 Ibid. 
173 Nutti, p. 75. 
174 Ibid. WT/DS291/R/Add.7 
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197. All three experts who responded to this questi on appear to agree that transgenic and non-
transgenic plants may result in unintended effects and that monitoring may be justified.  Dr. Snow 
concludes that both transgenic methods and other methods of crop breeding can result in unintended 
effects and that there is no basis to assume that these unintended effects would be substantially greater 
in transgenic plants.175  Moreover, she states that "it does not seem  logical to require monitoring if no 
risk has been identified."176 
198. Andow also points to "unanticipated effects" and agrees that some "conventional non-
transgenic plants have risks, some of wh ich may justify monitoring (and management)."177  Lastly, 
Dr. Nutti indicates that monitoring should be used in the same manner for biotech and novel non-
biotech based on scientific parameters. 
106. For those biotech products at issue in this dispute for which an approval has been sought for environmental release (notifications submitted under Directives 90/220 or 2001/18), 
and for which no significantly different nature or  level of risk has been identified, does the 
information before the Panel provide any scientifi c or technical rationale for requiring specific 
agricultural management practices that differ fr om those for novel non-biotech products, such 
as plant products produced by selective breed ing, cross-breeding and induced mutagenesis?  
 
199. Dr. Squire indicates that, provided no significant level or type of risk has been detected, then 
no particular change in practice above the highest  recommended existing practice to ensure a high 
purity should be needed.  If thresholds are imposed, for whatever reason, then there will need to be 
different agricultural practices for those GM varietie s that leave volunteers or spread genes by pollen 
to neighbouring sexually compatible crops.178  According to Dr. Squire, these different practices are 
well-appreciated, by which Canada takes him to mean that they are well-understood and of proven 
effectiveness. 
200. Dr. Squire also says that, under a system of coexistence in which a threshold (GM in non-
GM) was imposed, the agricultural practice might well ha ve to change in a crop such as oilseed rape 
to ensure that threshold would be met.  Importa ntly, he adds that, "given present knowledge, these 
changes would be in consequence of an imposed threshold of GM in non-GM products, not of any 
inherent food-risk in the GM product itself."179 
201. The basic point here is that any difference required in the agronomic management to preserve 
purity is a consequence of a policy decision to segregate GM crops from non-GM crops.  It would not 
be based on any scientific evidence demonstrating risk s to human, animal or plant health or safety. 
General Questions  
 
110. On the basis of the information before the Panel, is there any scientific evidence to support the hypothesis that animal feed made fr om biotechnology plants alters the composition 
of the food derived from animals consuming the feed?    
 
                                                      
175 Snow, p. 34. 
176 Ibid. 
177 Andow, p. 105.10. 
178 Squire, p. 17. 
179 Squire, p. 18.  WT/DS291/R/Add.7 
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                                                      (a) If so, what is the likelihood that this event could lead to adverse effects on 
human or animal health?  (see, inter alia , exhibit US-144)  
(b) What risk management options are available to mitigate any resulting risks and 
what is their efficacy? 
202. Dr. Nutti states in her response that she is "not aware of any scientific evidence that supports 
the hypothesis that animal feed made from biotec hnology plants alters the composition of the food 
derived from animals consuming the feed".180  She then refers to several studies that suggest there is 
no relationship between the use of biotech feed and the composition of food derived from animals 
given such feed.181 
112. Please provide an assessment of the statem ents regarding chronic toxicity testing in 
paragraph 43 of Canada's Third Submission a nd paragraphs 134-138 of the US Supplementary 
Rebuttal Submission.  What relevance does the forese en end product use(s) have in the context 
of the evaluation of the toxicity of that product?   
 
203. Dr. Nutti states in her answer that "if the toxi cological assessment has conducted acute agave 
studies in mice, homology to known toxins and al lergens with no indication of adverse effects, 
chronic toxicity tests shall not be required".182  She points to the relevant Codex Guidelines, which 
indicate that such tests may be necessary only if dou bts about the safety of the new substance remain.  
It should be added that such doubt s must have an empirical foundati on, and cannot simply arise on the 
basis of speculation. 
 
 
180 Nutti, p. 79. 
181 Ibid., p. 80. 
182 Ibid., p. 81.